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

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%.

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