The Week Ahead In Biotech (Aug. 1-7): Biopharma Earnings Pick Up Pace, Eton Awaits FDA Decision, Focus On Pending Clinical Readouts and IPOs

Biotech stocks showed a lack of direction in the week ending July 30 amid earnings releases from big pharma companies.

Most pharma majors reported strong quarterly results. Earnings momentum sent shares of Bristol-Myers Squibb Company BMY to a record high midweek, although they have pulled back since then. Pfizer, Inc.'s PFE COVID-19 vaccine sales buoyed its quarter results and prompted the company to raise its guidance. Merck & Co, Ltd. MRK, however, reported a bottom-line miss.

The Alzheimer's Association International Conference presentations moved stocks during the week. Annovis Bio, Inc. ANVS shares lost about 71% during the week after data presented at the conference failed to cut ice with investors.

The week also witnessed a slew of IPOs from among biopharma, diagnostics and medical devices companies.

Here are the key events/catalysts scheduled for the upcoming week:

PDUFA Dates

The Food and Drug Administration is scheduled to announce its verdict on Eton Pharmaceuticals, Inc.'s (NASDAQ: ETON) new drug application for topiramate oral solution. The decision is due by Friday, Aug. 6. The drug candidate is being evaluated as a treatment option for three indications – as a monotherapy for partial-onset or primary general tonic-clonic seizures in patients two years age and older, an adjunctive treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two years of age and older, and as preventative treatment for migraine patients 12 years of age and older.

Pending Regulatory Filings

Coherus BioSciences, Inc. CHRS: biologic license application filing for toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma as well as completion of rolling submission of BLA for toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma (middle of 2021)

bluebird bio, Inc. BLUE: completion of rolling BLA submission for approval of elivaldogene autotemcel gene therapy in patients with cerebral adrenoleukodystrophy as well betibeglogene autotemcel for transfusion-dependent β-thalassemia (middle of 2021)

Marinus Pharmaceuticals, Inc. MRNS: NDA filing for the use of ganaxolone in CDKL5 deficiency disorder (mid-2021)

Clinical Readouts

Pending Mid-2021 Releases

BeyondSpring Inc. BYSI: (DUBLIN-3): Topline overall survival data from pivotal Phase 3 non-small cell lung cancer study of plinabulin, dubbed DUBLIN-3

Celyad Oncology SA CYAD: additional data from the dose-escalation Phase 1 CYCLE-1 trial evaluating CYAD-02 in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome

F-star Therapeutics, Inc. FSTX: update on the progress of SB 11285 in the phase 1 clinical trial

Dynavax Technologies Corporation DVAX: Clover is due to release interim data for vaccine efficacy from the Phase 2/3 clinical trial evaluating the efficacy, safety, and immunogenicity of SCB-2019 in combination with Dynavax's CpG 1018 advanced adjuvant and alum.

Crinetics Pharmaceuticals, Inc. CRNX: preliminary Phase 1 data for CRN04894 in Cushing's disease and congenital adrenal hyperplasia and CRN04777 in congenital hyperinsulinism

Praxis Precision Medicines, Inc. PRAX: Preliminary topline data from the Phase 2a trial of PRAX-944 in essential tremor, and safety, tolerability and PK data from the ongoing Phase 1 trial of PRAX-562

MorphoSys AG MOR unit Constellation Pharma: Phase 1 data update for CPI-0209 in solid tumors and Phase 2 MANIFEST translational data update for pelabresib in myelofibrosis

Enanta Pharmaceuticals, Inc. ENTA: Phase 1 data for EDP-297 in non-alcoholic steatohepatitis

Dicerna Pharmaceuticals, Inc. DRNA: data from the PHYOX2 pivotal Phase 2 trial of nedosiran in patients with primary hyperoxaluria

Kaleido Biosciences, Inc. KLDO: Topline Phase 2 data from a clinical study of KB295 in patients with mild-to-moderate ulcerative colitis

INmune Bio, Inc. INMB: Data Safety Monitoring Board review of data from Phase 2 trial of Quellor in hospitalized COVID-19 patients suffering from pulmonary complications

Earnings

Monday

• Minerva Neurosciences, Inc. NERV (before the market open)
• SI-BONE, Inc. SIBN (after the close)
• Tuesday
• X4 Pharmaceuticals, Inc. XFOR (before the market open)
• Rhythm Pharmaceuticals, Inc. RYTM (before the market open)
• Myriad Genetics, Inc. MYGN (before the market open)
• Seres Therapeutics, Inc. MCRB (before the market open)
• Neuronetics, Inc. STIM (before the market open)
• Kiniksa Pharmaceuticals, Ltd. KNSA (before the market open)
• ADC Therapeutics SA ADCT (before the market open)
• Aptose Biosciences Inc. APTO (after the close)
• Theravance Biopharma, Inc. TBPH (after the close)
• Pulmonx Corporation LUNG (after the close)
• Invitae Corporation NVTA (after the close)
• Cytosorbents Corporation CTSO (after the close)
• Rigel Pharmaceuticals, Inc. RIGL (after the close)

Related Link: These 3 New Biotechs Have Differentiated Platforms, Technology: BofA

Wednesday

• TherapeuticsMD, Inc. TXMD (before the market open)
• Intellia Therapeutics, Inc. NTLA (before the market open)
• Surmodics, Inc. SRDX (before the market open)
• Vericel Corporation VCEL (before the market open)
• UroGen Pharma Ltd. URGN (before the market open)
• Horizon Therapeutics Public Limited Company HZNP (before the market open)
• IVERIC bio, Inc. ISEE (before the market open) (before the market open)
• Flexion Therapeutics, Inc. FLXN (after the close)
• Aerie Pharmaceuticals, Inc. AERI (after the close)
• AxoGen, Inc. AXGN (after the close)
• INmune (after the close)
• Bionano Genomics, Inc. BNGO (after the close)
• DermTech, Inc. DMTK (after the close)
• Fate Therapeutics, Inc. FATE (after the close)
• G1 Therapeutics, Inc. GTHX (after the close)
• Otonomy, Inc. OTIC (after the close)
• Xencor, Inc. XNCR (after the close)
• Celyad Oncology (after the close)

Click here to access Benzinga's FDA Calendar

Thursday

• Salarius Pharmaceuticals, Inc. SLRX (before the market open)
• OrthoPediatrics Corp. KIDS (before the market open)
• Mersana Therapeutics, Inc. MRSN (before the market open)
• Lumos Pharma, Inc. LUMO (before the market open)
• Karyopharm Therapeutics Inc. KPTI (before the market open)
• Galmed Pharmaceuticals Ltd. GLMD (before the market open)
• Jounce Therapeutics, Inc. JNCE (before the market open)
• Kala Pharmaceuticals, Inc. KALA (before the market open)
• Arena Pharmaceuticals, Inc. ARNA (before the market open)
• Antares Pharma, Inc. ATRS (before the market open)
• Arbutus Biopharma Corporation ABUS (before the market open)
• Aldeyra Therapeutics, Inc. ALDX (before the market open)
• Provention Bio, Inc. PRVB (before the market open)
• Autolus Therapeutics plc AUTL (before the market open)
• Wave Life Sciences Ltd. WVE (before the market open)
• Amarin Corporation plc AMRN (before the market open)
• Verona Pharma plc VRNA (before the market open)
• Chimerix, Inc. CMRX (before the market open)
• Concert Pharmaceuticals, Inc. CNCE (before the market open)
• Syros Pharmaceuticals, Inc. SYRS (before the market open)
• Stealth BioTherapeutics Corp MITO (before the market open)
• Strongbridge Biopharma plc SBBP (before the market open)
• Synthetic Biologics, Inc. SYN (after the close)
• CTI BioPharma Corp. CTIC (after the close)
• Y-mAbs Therapeutics, Inc. YMAB (after the close)
• Kura Oncology, Inc. KURA (after the close)
• Aligos Therapeutics, Inc. ALGS (after the close)
• Arcus Biosciences, Inc. RCUS (after the close)
• AVEO Pharmaceuticals, Inc. AVEO (after the close)
• Assertio Holdings, Inc. ASRT (after the close)
• Anika Therapeutics, Inc. ANIK (after the close)
• T2 Biosystems, Inc. TTOO (after the close)
• Caladrius Biosciences, Inc. CLBS (after the close)
• CytomX Therapeutics, Inc. CTMX (after the close)
• Collegium Pharmaceutical, Inc. COLL (after the close)
• Chembio Diagnostics, Inc. CEMI (after the close)
• Nabriva Therapeutics plc NBRV (after the close)
• Enanta Pharma (after the close)
• TransMedics Group, Inc. TMDX (after the close)
• iRhythm Technologies, Inc. IRTC (after the close)
• Sangamo Therapeutics, Inc. SGMO (after the close)
• Revance Therapeutics, Inc. RVNC (after the close)
• Spero Therapeutics, Inc. SPRO (after the close)
• Outset Medical, Inc. OM (after the close)
• Oncternal Therapeutics, Inc. ONCT (after the close)
• Natera, Inc. NTRA (after the close)
• Opiant Pharmaceuticals, Inc. OPNT (after the close)
• Novavax, Inc. NVAX (after the close)
• Mirum Pharmaceuticals, Inc. MIRM (after the close)
• Friday
• PLx Pharma Inc. PLXP (before the market open)
• ANI Pharmaceuticals, Inc. ANIP (before the market open)
• Twist Bioscience Corporation TWST (before the market open)
• Oncolytics Biotech Inc. ONCY (before the market open)
• Orthofix Medical Inc. OFIX (before the market open)

IPOs

IPO Pricing

Philadelphia, Pennsylvania-based Context Therapeutics, Inc. is planning an initial public offering of 1.5 million shares at an estimated price range of $12-$14. The company has applied for listing its shares on the Nasdaq under the ticker symbol CNTX. Context is a clinical-stage biopharmaceutical company developing therapies for women living with cancer.

Providence, Rhode Island-based Ocean Biomedical, Inc. has filed to offer 3.2258 million shares in an IPO. The company expects to price the offering in the range of $14-$17. The biopharma focuses on licensing tech and innovations and developing them into products. It has applied to list its shares on the Nasdaq under the ticker symbol OCEA.

IPO Quiet Period Expiry

• TransCode Therapeutics, Inc. RNAZ
• Unicycive Therapeutics, Inc. UNCY

Related Link: How Much A $1,000 Investment In Moderna Stock At the Time Of COVID-19 Vaccine Authorization Would Be Worth Today