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The Week Ahead In Biotech: Earnings, PDUFA Dates And More

Shanthi Rexaline

The volatile nature of biotech stocks is evident from the wild swings they experience in the wake of catalytic events, which in fact present profit-making opportunities for an astute investor.

This week saw Solid Biosciences Inc (NASDAQ: SLDB) plunge 60 percent after the FDA put its Phase 1/2 trial for its Duchenne muscular dystrophy treatment candidate SGT-001 on Clinical Hold.

Anthera Pharmaceuticals Inc (NASDAQ: ANTH) slumped 81 percent after a late-stage study of Sollpura to treat exocrine pancreatic insufficiency due to cystic fibrosis didn't meet the primary endpoint.

Meanwhile, Proteostasis Therapeutics Inc (NASDAQ: PTI) shares jumped 54 percent after it announced FDA granting breakthrough therapy designation for PTI-428 to treat cystic fibrosis.

Here're a few catalytic events scheduled for the upcoming week.

Clinical Trial Results

Sellas Life Sciences Group Inc (NASDAQ: SLS) is scheduled to make an oral presentation of an abstract of Phase 2 data on Galinpepimut-S, its multiple myeloma candidate, at the 2018 European Society for Blood and Marrow Transplantation, or EBMT, Annual Meeting at 10:50 a.m. ET on Monday, March 19.

Cellectis SA (ADR) (NASDAQ: CLLS) is due to present Phase 1 data on its refractory B-cell acute lymphoblastic leukemia, or ALL, treatment candidate UCART19-CALM at the EBMT on Wednesday, March 21.

Cellectis will also present data from a Phase I trial on UCART19(PALL-Pediatric Acute Lymphoblastic Leukemia) at the EBMT on March 21. Second interim data released at the ASH 2017 showed that all five children achieved minimal residual disease, or MRD, negativity at day 28, enabling allogenic stem cell transplantation.

ImmunoGen, Inc. (NASDAQ: IMGN) is scheduled to report updated dose-escalation findings from the FORWARD II mirvetuximab plus Keytruda combination cohort at the Society of Gynecologic Oncology annual meeting to be held between March 21-24. The combo is being tested for ovarian cancer and relapsed endometrial cancer.

See also: Morgan Stanley: Quest Diagnostics Has Balanced Risk-Reward


Monday, March 19

  • CytRx Corporation (NASDAQ: CYTR)
  • Fibrocell Science Inc (NASDAQ: FCSC)
  • aTyr Pharma, Inc. (NASDAQ: LIFE)

Thursday, March 22

  • HTG Molecular Diagnostics Inc (NASDAQ: HTGM)


After two unsuccessful attempts to go public, Israel-based Polypid, which specializes in therapies for several localized medical conditions, including infection, pain, inflammation and cancer, filed for a U.S. IPO on Feb. 8.

The company is expected to price its 3.33-million share offering on March 19, having estimated a price range of $21-$24 for the offering.

The company's lead candidate D-Plex, a slow-release antibiotic reservoir, is in a Phase 1b/2 trial to prevent bacterial infections at surgical sites. With the company aiming to start a Phase 3 program later this year, the proceeds from the proposed offering should come in handy.


  • European Society for Blood and Marrow Transplantation, or EBMT,'s 44th Annual Meeting - March 18-21 in Lisbon, Portugal
  • International Conference on Ureagenesis Defects: Novel Models and Treatment Options - March 19-21, 2018 in Engadin, Switzerland
  • 28th Annual Oppenheimer & Co. Healthcare Conference - March 20-21, 2018 at The Westin New York Grand Central in New York City
  • 49th Society of Gynecologic Oncology Annual Meeting - March 24-27, 2018 in New Orleans, Louisiana

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