ARNA Falls Short Of ADVICE, PFE's COVID-19 Vaccine Shows 90% Efficacy, SUPN Hit By Double Whammy

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Today's Daily Dose brings you news about encouraging efficacy data about Pfizer/BioNTech's COVID-19 vaccine candidate, Calliditas' primary IgA nephropathy trial results, FDA refusing to approve Supernus' ADHD drug candidate, a possible delay in the FDA decision of Revance's DaxibotulinumtoxinA for frown lines, and Affimed's licensing agreement with Roivant Sciences.

Read on…

1. Affimed Inks Licensing Deal with Roivant Sciences

Affimed N.V. (AFMD) has entered into a licensing and strategic collaboration agreement with global biopharmaceutical company Roivant Sciences to develop and commercialize novel Innate Cell Engagers or ICE molecules in oncology.

The agreement entitles Roivant a license to Affimed's preclinical molecule AFM32 with options for additional ICE molecules directed against targets not included in Affimed's current pipeline. In return, Affimed will receive $60 million in upfront consideration and up to an additional $2 billion in future milestones.

While Affimed will be primarily responsible for driving the discovery and research phases of molecule development through filing of the IND, Roivant will be responsible for clinical development and commercialization worldwide, and Affimed retains an option for co-promotion.

AFMD closed Monday's trading at $3.73, up 9.06%. In after-hours, the stock was up over 11% at $4.15.

2. Arena Falls Short Of ADVICE

Shares of Arena Pharmaceuticals Inc. (ARNA) were down over 17% in extended trading Monday, following news that its phase IIb trial evaluating Etrasimod for the treatment of moderate-to-severe atopic dermatitis failed to meet the primary endpoint.

In the phase IIb trial, dubbed ADVICE, the primary endpoint of Eczema Area and Severity Index (EASI) change from baseline at week 12 compared to placebo was not met.

However, Etrasimod in the primary analysis demonstrated statistical significance in percent change in EASI-75, and peak change in pruritis at week 4. Moreover, one-third of participants in the Etrasimod group achieved clear or almost clear skin, as defined by the validated Investigator Global Assessment (vIGA) - the FDA endpoint for Phase 3 registration.

Based on the compelling profile in this moderate atopic dermatitis population, the company has decided to advance Etrasimod into a phase III registrational program.

ARNA closed Monday's trading at $87.42, up 0.90%. In after-hours, the stock was down 17.66% at $71.98.

3. Calliditas' Phase 3 NefIgArd Trial Hits All Goals

Shares of Calliditas Therapeutics AB (CALT) touched a new high on Monday, following positive topline results from Part A of a global phase III clinical trial of Nefecon in patients with primary IgA nephropathy.

In the phase III trial, dubbed NefIgArd, the trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, or proteinuria, after 9 months of treatment, with significant continued improvement at 12 months. The trial also met the key secondary endpoint showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of treatment compared to placebo. The urine protein creatinine ratio and estimated glomerular filtration are important indicators of kidney function.

IgA nephropathy, also known as Berger's disease, is a kidney disease caused by the accumulation of a protein known as immunoglobulin A in kidneys, causing inflammation and damage to kidney tissues. IgA nephropathy often leads to the end-stage renal disease for which there no approved treatments. The market opportunity for Nefecon is estimated to be $9 billion to $10 billion in the U.S. alone.

Based on the encouraging results, Calliditas plans to seek accelerated approval for Nefecon from the FDA in Q1 2021 followed by a submission for conditional approval with the European Medicines Agency in H1 2021.

The part B of this phase III trial is designed to be a confirmatory post-market approval observational trial to confirm long-term renal protection.

CALT touched a high of $37.90 in intraday trading Monday, before closing at $33.95, up 34.88%.

4. Lilly's neutralizing antibody Gets Emergency Nod for Treating Recently Diagnosed COVID-19

Eli Lilly and Company's (LLY) investigational neutralizing antibody Bamlanivimab 700 mg has been authorized by the FDA for emergency use in the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

Bamlanivimab, which is administered via a single intravenous infusion, has shown to help patients clear the virus and reduce COVID-related hospitalizations, when given early in the disease course.

Lilly will begin shipping Bamlanivimab immediately to AmerisourceBergen, a national distributor, which will distribute it as directed by the U.S. government's allocation program.

LLY closed Monday's trading at $142.33, down 0.29%.

5. Novavax' COVID-19 Vaccine Candidate On Fast Track

Novavax Inc.'s (NVAX) COVID-19 vaccine candidate NVX-CoV2373, currently in phase III development, has been granted Fast Track designation by the FDA.

The ongoing phase III clinical trial of the vaccine candidate in the UK is expected to be fully enrolled by the end of November, with interim data expected as soon as early first quarter 2021.

The company expects to begin its pivotal phase III clinical trial of NVX-CoV2373 in the United States and Mexico by the end of November. Data from the trial could support global authorization and approval, including in the U.S.

NVAX closed Monday's trading at $90.31, up 0.50%.

6. Pfizer/BioNTech's COVID-19 Vaccine Candidate shows Over 90% Efficacy

Pfizer Inc. (PFE) and BioNTech SE's (BNTX) vaccine candidate BNT162b2 has found to be more than 90% effective in preventing COVID-19 based on the first interim analysis of their global phase III study.

The phase III trial evaluating BNT162b2 at 30 µg dose level in a 2 dose regimen began on July 27, and has enrolled 43,538 healthy participants to date, with 38,955 of them having received a second dose of the vaccine candidate as of November 8.

One of the primary endpoints of the trial is the prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and with a vaccine efficacy rate above 90%, it is proof that a vaccine may effectively prevent COVID-19.
The trial is ongoing and the final vaccine efficacy percentage may vary. The study also will evaluate the potential for BNT162b2 vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2.

No serious safety concerns have been reported.

Pfizer and BioNTech intend to seek Emergency Use Authorization for BNT162b2 from the FDA soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.

Pfizer expects to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

Pfizer touched a new high of $41.99 in intraday trading Monday, before closing at $39.20, up 7.69%. BNTX touched a new high of $115 in intraday trading before closing at $104.80, up 13.91%.

7. Revance Has Reasons To Frown

Revance Therapeutics, Inc. (RVNC), in its earnings PR, has disclosed that the FDA decision on its Biologics License Application for DaxibotulinumtoxinA for Injection in the treatment of moderate to severe glabellar (frown) lines, due on November 25, will be delayed.

An inspection of the Newark, California manufacturing site related to DaxibotulinumtoxinA is required prior to the FDA announcing its decision. However, the required inspection of the Revance manufacturing site by the regulatory agency has not been scheduled yet due to COVID-related travel restrictions.

In other news, the company announced that in a phase II clinical trial of DaxibotulinumtoxinA for Injection for the management of plantar fasciitis, the primary endpoint was not met.

Plantar fasciitis is a painful affliction caused by inflammation of the ligament running along the bottom of the foot.

The study's primary efficacy endpoint was the change from baseline on the 10-point Numeric Pain Rating Scale (NPRS) score for foot pain.

Although patients treated with DaxibotulinumtoxinA reported significant pain reduction that was numerically greater than placebo, it was not statistically significant.

A phase II trial of DaxibotulinumtoxinA for upper limb spasticity, dubbed JUNIPER, is underway, with topline results expected in Q1, 2021.

RVNC closed Monday's trading at $27.60, up 3.99%. In after-hours, the stock was down 5.80% at $26.00.

8. Supernus Hit By Double Whammy

Shares of Supernus Pharmaceuticals Inc. (SUPN) plunged over 22% in extended trading, following a double dose of disappointing news.

The FDA has refused to approve SPN-812, a novel non-stimulant for the treatment of attention-deficit hyperactivity disorder, and declined to even accept for review the company's New Drug Application for SPN-830 for the continuous treatment of motor fluctuations ("on-off" episodes) in Parkinson's disease.

The primary issue for denying FDA approval to SPN-812 is related to the company's in-house laboratory that conducts analytical testing, which recently moved to a new location. No clinical safety or efficacy issues were raised identified during the review.

As for the SPN-830 New Drug Application, which was submitted to the FDA in September 2020, it has been deemed to be not sufficiently complete to permit a substantive review. The regulatory agency has requested certain documents and reports to be submitted in support of the application.

SUPN closed Monday's trading at $24.95, up 5.81%. In after-hours, the stock was down 22.85% at $19.25.

9. Stocks That Hit New Highs/Lows

Catalent Inc. (CTLT) closed Monday's trading at a new high of $101.91, down 1.36%.

Kodiak Sciences Inc. (KOD) closed Monday's trading at a new high of $113.17, up 4.22%.

SQZ Biotechnologies Company (SQZ) closed Monday's trading at a new high of $21.75, up 8.75%.

Assertio Holdings, Inc. (ASRT) closed Monday's trading at a new low of $0.39, down 18.02%.

Atea Pharmaceuticals Inc. (AVIR) closed Monday's trading at a new low of $26.36, down 22.86%.

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