The Week Ahead In Biotech (March 27-April 2): Lipocine, Akebia, Merck Await FDA Verdicts, Adcom Test For Amylyx, BioNTech Earnings And More

Zinger Key Points
  • The FDA is set to rule on Lipocine Inc.'s new drug application for Tlando.
  • The FDA's Peripheral and Central Nervous System Drugs Advisory Committee is scheduled to meet on Wednesday.

Biotech stocks reversed course in the week ending March 25, as an increase in risk appetite prompted traders to move money out of defensives and into risky bets.

Among noteworthy developments in the space, Novartis AG NVS announced the FDA nod for its radioligand therapy Pluvicto for metastatic castration-resistant prostate cancer, for patients who test positive for the prostate-specific membrane antigen with an FDA-approved imaging diagnostic agent.

Meanwhile, the decision date for Bristol-Myers Squibb Co's BMY application for expanding the label for Reblozyl to treat non-transfusion dependent beta thalassemia was pushed back by three months.

Icosavax, Inc. (ICVX) pulled back on a negative Phase 1/2 readout and MEI Pharma, Inc. (MEIP) came under intense selling pressure after the Food and Drug Administration poured cold water on its plan to get accelerated approval for zandelisib in follicular lymphoma.

Here are the key catalysts that could move biopharma stocks in the unfolding week:


American Academy of Dermatology, or AAD, Annual Meeting: March 25-29, in Boston, Massachusetts

Stifel 2022 CNS Days: March 28-29 (virtual)

Guggenheim Genomic Medicines and Rare Disease Day Conference: March 30-April 1 (virtual)

ESMO's European Lung Cancer Congress: March 30-April 2 (virtual)

The American College of Cardiology, or ACC,'s 71st Annual Scientific Session & Expo: April 2-4, in Washington DC


The FDA is set to rule on Lipocine Inc.'s LPCN new drug application for Tlando, an oral prodrug of testosterone containing testosterone undecanoate, on Monday, March 28. Tlando has received tentative approval from the FDA in December for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

The final approval was delayed, as the exclusivity period previously granted to Clarus Therapeutics' rival product Jatenzo expires only on March 27. Lipocine has an exclusive licensing agreement with Antares Pharma, Inc. ATRS for marketing Tlando in the U.S.

Akebia Therapeutics, Inc. AKBA has a PDUFA date of Tuesday, March 29 for its NDA of vadadustat for treating anemia in chronic kidney disease patients.

The drug regulator is also scheduled to announce its verdict on Merck & Co., Inc.'s MRK supplemental biologics license application for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age. The FDA set a PDUFA date, of Friday, April 1.

Adcom Calendar

FDA's Peripheral and Central Nervous System Drugs Advisory Committee is scheduled to meet on Wednesday, March 30 to discuss Amylyx Pharmaceuticals, Inc.'s AMLX NDA for sodium phenylbutyrate/taurursodiol powder for oral suspension, for the treatment of amyotrophic lateral sclerosis.

Clinical Readouts/Presentations

Aldeyra Therapeutics, Inc. ALDX will announce at its R&D day, scheduled for Tuesday, top-line data from the Phase 2 proof-of-concept clinical trials of ADX-629 in three types of inflammatory disease.

Replimune Group, Inc. REPL is due to present at its virtual investor event, scheduled for Wednesday, updated data from the completed cohorts of the Phase 2 clinical trial of RP1 in non-melanoma skin cancer and melanoma. Additionally, the company will also present new data from the ongoing clinical trial in anti-PD1 failed NMSC and from the Phase 1b/2 clinical trial of RP1 as monotherapy in solid organ transplant recipients with skin cancer.

Immutep Limited IMMP will present at the ESMO European Lung Cancer Conference additional safety and efficacy data for eftilagimod along with Merck's Keytruda in second-line confirmed PD-1/PD-L1 refractory, non-small cell lung cancer patients. (Friday)

ACC Meeting Presentations

Lexicon Pharmaceuticals, Inc. LXRX: Analysis of sotagliflozin data from the SCORED Phase 3 clinical trial (Saturday, at 12 pm)

Cytokinetics, Incorporated CYTK: Phase 2 cohort 3 efficacy and safety data for aficamten and disopyramide coadministration in obstructive hypertrophic cardiomyopathy (Saturday)

Related Link: Ahead Of Moderna's Midstage mRNA Flu Vaccine Readout, Analyst Says Drugmaker Likely To Be First To Market


The earnings list presented is not comprehensive. Click here to access Benzinga's earnings calendar for the complete schedule.


Iterum Therapeutics plc ITRM (before the market open)
Brainstorm Cell Therapeutics Inc. BCLI (before the market open)
Cyclacel Pharmaceuticals, Inc. CYCC (after the close)


SCYNEXIS, Inc. SCYX (before the market open)
Kala Pharmaceuticals, Inc. KALA (before the market open)
I-Mab IMAB (before the market open)
Humacyte, Inc. HUMA (before the market open)
Ampio Pharmaceuticals, Inc. AMPE (before the market open)
BioCardia, Inc. BCDA (after the close)
CorMedix Inc. CRMD (after the close)
Dyadic International, Inc. DYAI (after the close)
HTG Molecular Diagnostics, Inc. HTGM (after the close)
Tricida, Inc. TCDA (after the close)
OpGen, Inc. OPGN (after the close)
PAVmed Inc. PAVM (after the close)
NovaBay Pharmaceuticals, Inc. NBY (after the close)
Nabriva Therapeutics plc NBRV (after the close)


BiomX Inc. PHGE (before the market open)
EDAP TMS S.A. EDAP (before the market open)
BioNTech SE BNTX (before the market open)
PolarityTE, Inc. PTE (before the market open)
Centogene N.V. CNTG (before the market open)
Axcella Health Inc. AXLA (before the market open)
Alaunos Therapeutics, Inc. TCRT (before the market open)
Atai Life Sciences N.V. ATAI (before the market open)
Orchard Therapeutics plc (ORTX) (before the market open)
Agile Therapeutics, Inc. AGRX (after the close)
Acutus Medical, Inc. AFIB (after the close)
KemPharm, Inc. KMPH (after the close)
ENDRA Life Sciences Inc. NDRA (after the close)
RVL Pharmaceuticals plc RVLP (after the close)


Taysha Gene Therapies, Inc. TSHA (before the market open)
PDS Biotechnology Corporation PDSB (before the market open)
Affimed N.V. AFMD (before the market open)
Adamis Pharmaceuticals Corp (NASDAQ: ADMP) (after the close)
INVO Bioscience, Inc. INVO (after the close)
Calithera Biosciences, Inc. CALA (after the close)
Inhibikase Therapeutics, Inc. IKT (after the close)
Spero Therapeutics, Inc. SPRO (after the close)
Biocept, Inc. BIOC

Related Link: Merck Continues to See Executive Exodus; Here's A Look At All Recent Departures

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