KMPH Scores FDA Nod For ADHD Drug, MNOV Quits COVID-19 Vaccine Race, UTHR Gives Up On Trevyent


2021-03-05 12:51:54 RTTNews


Today's Daily Dose brings you news about KemPharm scoring regulatory nod for its ADHD drug, expanded FDA approval for Pfizer's Lorbrena, United Therapeutics scrapping the development of Trevyent, Vir Biotechnology closing the enrollment in VIR-7831 arm of ACTIV-3 trial, and Takeda securing global rights to Ovid's investigational medicine Soticlestat. Read on… 1.KemPharm Scores FDA Nod For ADHD Drug KemPharm Inc. (KMPH) soared more than 42% on Wednesday, following FDA approval of AZSTARYS (formerly referred to as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. AZSTARYS consists of Serdexmethylphenidate (SDX) co-formulated with immediate-release d-methylphenidate (d-MPH). The drug will compete against currently marketed, branded and generic methylphenidate products for the treatment of attention deficit hyperactivity disorder (ADHD). Some of these currently marketed products include Johnson & Johnson's Concerta, Novartis AG's Ritalin, Ritalin LA, Focalin and Focalin XR, UCB S.A.'s Metadate CD, and Noven Pharmaceuticals' Daytrana. The peak sales of AZSTARYS are pegged at over $300 million by analysts. AZSTARYS is expected to be commercially available in the U.S. as early as the second half of 2021. Corium Inc. , a portfolio company of Gurnet Point Capital (GPC), will lead the commercialization of AZSTARYS. KMPH closed Wednesday's trading at $13.47, up 42.84%. 2. MediciNova Quits the COVID-19 Vaccine Race MediciNova Inc. (MNOV) has decided to discontinue the development of its SARS-CoV-2 vaccine for COVID-19 after a careful review. The company, along with BioComo, was developing an intranasal Respiratory Syncytial (RS) virus vaccine using BC-PIV technology, for SARS-CoV-2, the virus responsible for COVID-19. The vaccine is under preclinical testing. MediciNova has decided to quit the COVID-19 vaccine race in order to maintain adequate resources for its other development programs which have indications with larger unmet medical needs and market opportunities. MNOV closed Wednesday's trading at $5.59, down 1.93%. 3. Ocugen's Partner Releases first interim results of COVAXIN Ocugen Inc.'s (OCGN) co-development partner, Bharat Biotech, has shared the first interim results of COVAXIN, which has demonstrated nearly 81% efficacy in a phase III trial in India. COVAXIN, a whole virion inactivated COVID-19 vaccine candidate, is under a phase III trial in India, which is being conducted by Bharat Biotech. The phase III clinical trial enrolled 25,800 participants between 18-91 years of age, including 2,433 over the age of 60 and 4,500 participants with comorbidities. The primary endpoint of the Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group compared to just 7 cases observed in the COVAXIN group, which translates to an efficacy rate of 80.6%. COVAXIN was authorized for emergency use in India on January 3, 2021. Bharat Biotech plans to release further details of the trial results as additional data become available. OCGN closed Wednesday's trading at $10.46, up 8.96%. 4. Takeda Secures Global Rights to Ovid's Soticlestat Shares of Ovid Therapeutics Inc. (OVID) soared more than 36% on Wednesday, on news of Takeda securing global rights to the company's investigational medicine Soticlestat. Soticlestat, discovered at Takeda's Shonan, Japan research center, was licensed to Ovid in 2017. This drug candidate is being developed for the treatment of developmental and epileptic encephalopathies, including Dravet syndrome (DS) and Lennox-Gastaut syndrome. Under the 2017 collaboration agreement, Takeda received equity in Ovid and was eligible to receive up to $85 million in payments for regulatory milestones, including the initiation of Phase 3 clinical trials. Now that Takeda has secured all the global rights to Soticlestat, Ovid will have no further development or milestone obligations. Ovid is now eligible to receive from Takeda up to $856 million in payments, including a $196 million upfront payment, regulatory and commercial milestone payments and tiered double-digit royalties on product sales. Takeda plans to initiate Phase 3 studies of Soticlestat in children and adults with Dravet syndrome and Lennox-Gastaut syndrome next quarter. OVID closed Wednesday's trading at $4.04, up 36.49%. 5. FDA Approves Expanded Indication for Pfizer's Lorbrena The FDA has approved the expanded label for Pfizer Inc.'s (PFE) Lorbrena as first-line treatment for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer. The expanded approval was based on results of a phase III trial in patients with previously untreated advanced ALK-positive NSCLC who were randomized to receive LORBRENA monotherapy or XALKORI monotherapy. In the trial, dubbed CROWN, there was a 72% reduction in risk of progression or death for treatment with LORBRENA compared to XALKORI. (XALKORI, developed by Pfizer, is an approved drug for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive or ROS1-positive). Lorbrena received accelerated approval from the FDA in 2018 for the treatment of patients with ALK-positive metastatic NSCLC whose disease has progressed on Crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on Alectinib or Ceritinib as the first ALK inhibitor therapy for metastatic disease. Now, with the FDA approving the expanded use, the 2018 accelerated approval has also been converted to full approval. Sales of Lorbrena are not reported individually in the company's financial statement. PFE closed Wednesday's trading at $34.39, up 2.63%. 6. United Therapeutics Throws In the Towel on Trevyent United Therapeutics Corporation (UTHR) has decided to discontinue the development of its drug device combination product candidate Trevyent, proposed for the treatment of pulmonary arterial hypertension. Trevyent was denied FDA approval in April 2020, and following a meeting with the regulatory agency, the company has now received its feedback. The FDA has indicated that the company would need to both redesign the product to improve pump accuracy in certain respects and conduct a clinical study of the redesigned product - all of which would cause considerable additional delay and additional development efforts may not ultimately be successful in addressing the FDA's comments. Since the development of Trevyent is no longer commercially reasonable in light of the additional FDA feedback, the company has decided to scrap its development. UTHR closed Wednesday's trading at $163.21, down 2.03%. 7. Vir Biotechnology To Close Enrollment in VIR-7831 arm of COVID-19 Trial Shares of Vir Biotechnology Inc. (VIR) plunged over 27% on Wednesday, following an independent Data and Safety Monitoring Board's recommendation to close enrollment in the VIR-7831 arm of ACTIV-3 trial while the data mature. ACTIV-3, a global Phase 3 trial, is one of several ongoing trials in the National Institutes of Health's Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. Following a routine, pre-planned safety and efficacy data review of the first 300 patients hospitalized with COVID-19 enrolled in the ACTIV-3 trial, the independent Data and Safety Monitoring Board has found that while VIR-7831 met initial pre-specified criteria to continue to the next phase of the ACTIV-3 trial and there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of potential benefit. Vir Biotechnology is partnered with GlaxoSmithKline plc (GSK) to develop VIR-7831.The companies will continue discussions with the NIH about the best ways to further evaluate the potential of VIR-7831 in the hospitalized population as all parties gain a fuller understanding of the still-emerging data. VIR closed Wednesday's trading at $41.78, down 27.64%. 8. Stocks That Gained/Lost The Most In a Day Asensus Surgical Inc. (TRXC) closed Wednesday's (Mar.3, 2021) trading at $4.54, up 15.82%. Guardion Health Sciences Inc. (GHSI) closed at $2.82, up 12.80%. Magenta Therapeutics Inc. (MGTA) closed at $13.18, up 11.60%. Sana Biotechnology, Inc. (SANA) closed at $24.48, down 18.02%. Lucira Health Inc. (LHDX) closed at $15.45, down 15.44%. For comments and feedback contact: Business News
今天的每日剂量为您带来的新闻是:KemPharm公司获得了ADHD药物的监管批准,FDA扩大了对辉瑞公司Lorbrena的批准,United Therapeutics公司取消了Trevyent的开发,Vir Biotechnology关闭了VIR-7831 arm的Active-3试验,以及Takeda公司获得了Ovid公司研究药物Soticlestat的全球权利。 继续阅读… 1.Kempharm为ADHD药物的FDA Nod评分 KemPharm公司(KMPH)周三股价飙升超过42%,此前FDA批准了AZSTARYS(前称KP415),这是一种每日一次的产品,用于治疗6岁及以上患者的注意力缺陷多动障碍(ADHD)。 AZSTARYS由哌酸塞地克甲酯(SDX)与速释D-哌酸甲酯(d-MPH)联合配制而成。该药将与目前上市的、品牌的和通用的哌甲酯产品竞争,用于治疗注意力缺陷多动障碍(ADHD)。目前销售的一些产品包括强生公司的Concerta、诺华公司的Ritalin、Ritalin LA、Focalin和Focalin XR、UCB S.A.的Metadate CD和Noven Pharmaceuticals的Daytrana。 分析师预计AZSTARYS的最高销售额超过3亿美元。 预计AZSTARYS最早将于2021年下半年在美国商用。Gurnet Point Capital(GPC)的投资组合公司Corium Inc.将领导Azstarys的商业化。 KMPH周三收盘报13.47美元,上涨42.84%。 2.MediciNova退出新冠疫苗竞赛 MediciNova公司(MNOV)经过仔细审查后,决定停止其新型冠状病毒新冠疫苗的开发。 该公司与BioComo合作,正在利用BC-PIV技术开发一种鼻内呼吸道合胞体(RS)病毒疫苗,用于感染COVID-19的新型冠状病毒病毒。疫苗正在进行临床前试验。 MediciNova公司已决定退出新冠疫苗竞赛,以便为其其他开发项目保持充足的资源,这些项目的适应症有更大的医疗需求和市场机会未得到满足。 姆诺夫周三收盘报5.59美元,下跌1.93%。 3.Ocugen的合作伙伴发布了COVAXIN的首个中期结果 Ocugen公司(OCGN)的共同开发伙伴Bharat Biotech分享了COVAXIN的第一个中期结果,在印度的III期试验中,COVAXIN显示了近81%的疗效。 全病毒粒子灭活新冠疫苗候选疫苗COVAXIN正在印度进行三期试验,由巴拉特生物技术公司进行。 III期临床试验纳入了25,800名年龄在18-91岁之间的参与者,其中包括2433名60岁以上的参与者和4,500名患有合并症的参与者。3期临床试验的主要终点基于基线时血清学阴性(对新型冠状病毒)的成年参与者在第二次研究疫苗接种后至少14天首次出现PCR确认的症状(轻度、中度或重度)COVID-19。 第一项中期分析基于43例病例,其中安慰剂组观察到36例COVID-19病例,而柯瓦新组仅观察到7例,其有效率为80.6%。 COVAXIN于2021年1月3日在印度获得紧急使用授权。 Bharat Biotech计划在获得更多数据后公布试验结果的更多细节。 OCGN周三收盘报10.46美元,上涨8.96%。 4.武田确保奥维德的Soticlestat的全球版权 Ovid Therapeutics Inc.(Ovid)的股价周三飙升超过36%,因为竹田获得了该公司研究药物Soticlestat的全球版权。 Soticlestat是在武田的Shonan日本研究中心发现的,于2017年被授权给Ovid。这种候选药物正在开发中,用于治疗发育性和癫痫性脑病,包括Dravet综合征(DS)和Lennox-Gastaut综合征。 根据2017年的合作协议,武田获得了奥维德的股权,并有资格获得高达8500万美元的监管里程碑付款,包括启动3期临床试验。现在,武田已经获得了Soticlestat的所有全球权利,奥维德将没有进一步的开发或里程碑义务。 奥维德现在有资格从武田获得高达8.56亿美元的付款,包括1.96亿美元的预付款、监管和商业里程碑付款以及产品销售的分层两位数版税。 Takeda计划下个季度在患有Dravet综合征和Lennox-Gastaut综合征的儿童和成人中启动索替克司他的3期研究。 奥维德周三收盘报4.04美元,上涨36.49%。 5.FDA批准辉瑞公司的Lorbrena扩大适应症 FDA已经批准了辉瑞公司(PFE)的Lorbrena的扩展标签,作为间变性淋巴瘤激酶(ALK)阳性非小细胞肺癌的一线治疗药物。 扩大的批准是基于一项III期试验的结果,该试验的患者是先前未经治疗的晚期ALK阳性的NSCLC患者,他们随机接受LORBRENA单药疗法或XALKORI单药疗法。在这项名为CROWN的试验中,与Xalkori相比,LORBRENA治疗的进展或死亡风险降低了72%。(辉瑞公司开发的XALKORI是一种被批准用于治疗肿瘤为ALK阳性或ROS1阳性的晚期非小细胞肺癌(NSCLC)患者的药物)。 Lorbrena于2018年获得FDA的加速批准,用于治疗ALK阳性的转移性NSCLC患者,其疾病在克唑替尼和至少一种其他用于转移性疾病的ALK抑制剂治疗下进展;或其疾病已经进展的阿列克替尼或赛利替尼作为第一个ALK抑制剂治疗转移性疾病。 如今,随着FDA批准扩大使用,2018年的加速审批也转为全面审批。 Lorbrena的销售未在本公司的财务报表中单独报告。 PFE周三收盘报34.39美元,上涨2.63%。 6.联合治疗公司对特雷文特投了一张毛巾 联合治疗公司(UTHR)已决定停止其药物器械组合产品候选Trevyent的开发,该产品拟用于治疗肺动脉高压。 Trevyent于2020年4月被FDA拒绝批准,在与监管机构举行会议后,该公司现已收到其反馈。 FDA指出,该公司需要重新设计产品以提高泵的某些方面的精度,并对重新设计的产品进行临床研究--所有这些都将导致相当多的额外延迟,而且额外的开发努力最终可能无法成功地解决FDA的评论。 由于根据FDA的额外反馈,Trevyent的开发不再具有商业合理性,该公司决定放弃其开发。 UTHR周三收盘报163.21美元,下跌2.03%。 7.Vir Biotechnology将关闭VIR-7831 arm新冠病毒试验的注册 Vir Biotechnology Inc.(Vir)的股价周三暴跌超过27%,此前一个独立的数据和安全监测委员会建议在数据成熟时关闭Active-3试验的VIR-7831部分的注册。 ACTIV-3是一项全球3期试验,是美国国家卫生研究院加速COVID-19治疗干预和疫苗(ACTIV)计划中几项正在进行的试验之一。这项试验旨在评估VIR-7831治疗住院成人新冠肺炎患者的安全性和疗效。 在对ACTIV-3试验中登记的首批300名COVID-19住院患者进行例行、预先计划的安全性和有效性数据审查后,独立数据和安全监测委员会发现,虽然VIR-7831符合最初预先规定的标准,可以继续进入ACTIV-3试验的下一阶段,并且没有报告的安全信号,但对现有数据的敏感性分析引起了对潜在获益幅度的担忧。 Vir Biotechnology与葛兰素史克公司(GSK)合作开发VIR-7831。随着各方对仍在出现的数据有更充分的了解,两家公司将继续与NIH讨论进一步评估VIR-7831在住院人群中的潜力的最佳方法。 VIR周三收盘报41.78美元,下跌27.64%。 8.日内涨幅/跌幅最大的股票 Asensus Surgical Inc.(TRXC)周三(2021年3月3日)收盘报4.54美元,上涨15.82%。 Guardion Health Sciences公司(GHSI)收报2.82美元,上涨12.80%。 洋红治疗公司(MGTA)收报13.18美元,上涨11.60%。 萨那生物技术公司(Sana)收报24.48美元,下跌18.02%。 卢西拉健康公司(LHDX)收报15.45美元,下跌15.44%。 如需评论和反馈,请联系 商业新闻