The Week Ahead In Biotech: Mediwound, Provention FDA Decisions, IPOs, Pending Clinical Readouts In Focus

Biotech stocks reversed course and closed the week ended June 25 higher, thanks to the positive broader market sentiment.

Eli Lilly and Company LLY stood out among big pharma stocks as it capitalized on its announcement regarding its intention to apply for regulatory approval of its Alzheimer's candidate donanemab.

Coronavirus vaccine stocks  Pfizer, Inc. PFE and Moderna, Inc. MRNA experienced some weakness mid-week after a CDC panel found correlation between the companies' mRNA vaccines and cases of heart inflammation in young adults.

Atossa Therapeutics, Inc. ATOS was among the biggest gainers of the week as recent news flow continued to impart momentum to the stock. The stock is set to join the Russell 2000 and 3000 Indexes next week.

The week also witnessed presentations at several medical conferences, with the International Liver Congress being the chief among them, and a slew of biotech IPOs.

Here are the key catalysts for the unfolding week.

Conferences

The European Society for Medical Oncology, or ESMO, World Congress on Gastrointestinal Cancer: June 30-July 3

Related Link: 14 Biotech Stocks To Watch Over The Next 6 Months

PDUFA Dates

The Food and Drug Administration is scheduled to rule on MediWound Ltd.'s MDWD biologic license application for NexoBrid for eschar removal in adults with deep partial-thickness and/or full-thickness thermal burns. MediWound, an Israeli biopharma, has granted the North American license to NexoBrid to Vericel Corporation VCEL under a May 2019 agreement. The PDUFA goal date is set for Tuesday, June 29.

The FDA will also announce its verdict on Provention Bio, Inc.'s PRVB BLA for teplizumab by the July 2 PDUFA goal date. Teplizumab is an investigational anti-CD3 monoclonal antibody being evaluated for the delay or prevention of clinical type 1 diabetes in at-risk individuals.

Clinical Trials/Presentations

ALX Oncology Holdings Inc. ALXO will present at the ESMO meeting additional results from a Phase 1b study (ASPEN-01) of ALX148 in combination with trastuzumab, ramucirumab and paclitaxel in patients with HER2-positive gastric/gastroesophageal junction cancer. (Thursday)

Pending Q2/H1/June Releases

Q2 Releases

I-Mab IMAB: results from the interim analysis of Phase 2 study of plonmarlimab in COVID-19

AzurRx BioPharma, Inc. AZRX: full topline results from all 20 patients enrolled in the combination trial evaluating MS1819 in combination with porcine-derived pancreatic enzyme replacement therapy, the current standard of care, for the treatment of severe exocrine pancreatic insufficiency in cystic fibrosis patients

Evaxion Biotech A/S EVAX: Phase 1/2a data readouts for lead programs EVX-01 in melanoma/non-small cell lung cancer/bladder cancer and EVX-02 as adjuvant treatment for melanoma

Cerecor Inc. CERC: initial data for CERC-002 in Crohn's disease

OptiNose, Inc. OPTN: topline results from the proof-of-concept study of OPN-019 in subjects who have tested positive for SARS-CoV-2 recently and who have mild or no symptoms

Citius Pharmaceuticals, Inc. CTXR: results from the interim analysis of Phase data for Mino-Lok for treating catheter-related bloodstream infection

Insmed Incorporated INSM: topline data from the investigator-initiated STOP-COVID19 Phase 3 trial of brensocatib in hospitalized patients with COVID-19

Rocket Pharmaceuticals, Inc. RCKT: updated process B data from Phase 1/2 study of RP-L102 in Fanconi anemia

PTC Therapeutics, Inc. PTCT: Phase 1 data for PTC857 in healthy volunteers

NeuroBo Pharmaceuticals, Inc. NRBO: data monitoring committee safety results of the Phase 1 study of ANA001 in moderate to severe COVID-19 patients

NovoCure Limited NVCR: full data from phase 2 pilot HEPANOVA trial in advanced liver cancer

Exelixis, Inc. EXEL & Takeda Pharmaceutical Company Limited TAK: top-line results from the phase 3 COSMIC-312 pivotal trial evaluating the combination of cabozantinib and atezolizumab as a first-line treatment in advanced hepatocellular carcinoma

Kintara Therapeutics, Inc. KTRA: topline Phase 2 results for VAL-083 in unmethylated recurrent glioblastoma multiforme

H1 Releases

Angion Biomedica Corp. ANGN: topline Phase 2 data for ANG-3777 in acute lung injury associated with COVID-19-related pneumonia and Phase 1 data for ANG-3070 from healthy volunteer study

Krystal Biotech, Inc. KRYS: updated Phase 2 data on KB105 for transglutaminase-1 deficient autosomal recessive congenital ichthyosis

Longeveron Inc. (LGVN): final results of the Phase 1 HLHS study of lomecel-B for hypoplastic left heart syndrome

June Releases

Altimmune, Inc. ALT: Data readouts from Phase 1 study of AdCOVID, its intranasal vaccine candidate for COVID-19, and ALT-801 study

Ocuphire Pharma, Inc. OCUP: Phase 2 Presbyopia data for a kit combination of Nyxol and low-dose 0.4% pilocarpine

Earnings

Avid Bioservices, Inc. CDMO (Tuesday, after the close)

Valeo Pharma Inc. VPHIF (Tuesday, after the close)

Affimed N.V. AFMD (Thursday, before the market open)

Related Link: Orphazyme Wild Party At Risk As FDA Rejects Its Rare Neurodegenerative Disease Drug

IPOs

IPO Pricing

Hong Kong-based Regencell Bioscience Holdings Limited is proposing to offer 2.3 million shares in an initial public offering. The company expects to price the IPO between $8.50 and $10.50 and has applied to list the shares on the Nasdaq under the ticker symbol RGC. Regencell focuses on treatments for neurocognitive disorders and degeneration, specifically attention deficit hyperactivity disorder and autism spectrum disorder.

Minnesota-based medical device maker CVRx has filed for offering 6.25 million shares of its common stock in an IPO. The estimated price range for the offering is $15-$17. The commercial-stage medical device company focused on developing and commercializing minimally invasive neuromodulation solutions for patients with cardiovascular diseases expects to list its shares on the Nasdaq under the ticker symbol CVRX.

Acumen Pharmaceuticals, Inc., a clinical-stage biopharma working on Alzheimer's disease treatment, is planning an 8.33-million share IPO at an estimated price range of $14-$16. The Charlottesville, Virginia-based company has applied for listing its shares on the Nasdaq under the ticker symbol ABOS.

Boston, Massachusetts-based Aerovate Therapeutics, Inc. has filed for offering 7.15 million shares in an IPO. The clinical-stage biopharma focusing on treatments for cardiopulmonary diseases expects the offering to be priced between $13 and $15. The company has applied for listing its shares on the Nasdaq under the ticker symbol AVTE.