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The Daily Biotech Pulse: BioCryst's Heredity Angioedema Treatment Clears FDA, Sutro Biopharma Readout, 2 IPOs

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·6 min read
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Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Dec. 3)

  • Atara Biotherapeutics Inc (NASDAQ: ATRA)

  • Beam Therapeutics Inc (NASDAQ: BEAM)

  • Bioanalytical Systems, Inc. (NASDAQ: BASI)

  • Cellectis SA (NASDAQ: CLLS)

  • Cerevel Therapeutics Holdings Inc (NASDAQ: CERE)

  • Crispr Therapeutics AG (NASDAQ: CRSP)

  • Fate Therapeutics Inc (NASDAQ: FATE)

  • Generation Bio Co (NASDAQ: GBIO)

  • Glaukos Corp (NYSE: GKOS)

  • Idera Pharmaceuticals Inc (NASDAQ: IDRA)

  • Infinity Pharmaceuticals Inc. (NASDAQ: INFI)

  • Inhibrx Inc (NASDAQ: INBX)

  • Intellia Therapeutics Inc (NASDAQ: NTLA)

  • Inspire Medical Systems Inc (NYSE: INSP)

  • Masimo Corporation (NASDAQ: MASI)

  • NeoGenomics, Inc. (NASDAQ: NEO)

  • Ocular Therapeutix Inc (NASDAQ: OCUL)

  • Pacific Biosciences of California Inc (NASDAQ: PACB)

  • Paratek Pharmaceuticals Inc (NASDAQ: PRTK)

  • Precigen Inc (NASDAQ: PGEN)

  • PTC Therapeutics, Inc. (NASDAQ: PTCT)

  • Spero Therapeutics Inc (NASDAQ: SPRO)

  • Syndax Pharmaceuticals Inc (NASDAQ: SNDX)

  • Twist Bioscience Corp (NASDAQ: TWST)

  • Ultragenyx Pharmaceutical Inc (NASDAQ: RARE)

  • Veracyte Inc (NASDAQ: VCYT)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Dec. 3)

  • Histogen Inc (NASDAQ: HSTO)

Stocks In Focus Sutro Reports Positive Results For Early-stage Study of Antibody-drug Conjugate In Ovarian Cancer

Sutro Biopharma Inc (NASDAQ: STRO) announced updated data from its ongoing dose-escalation Phase 1 study of STRO-002, an antibody-drug conjugate, for patients with ovarian cancer, showing that out of the 31 evaluable patients, 10 patients met RECIST criteria. Out of these 10 patients, one achieved a complete response and nine achieved a partial response, with three confirmed and six unconfirmed partial responses.

The company said 23 patients of the 31 evaluable patients achieved disease control at 12 weeks and 18 achieved disease control at 16 weeks.
STRO-002 was also found to be well-tolerated and 86% of all treatment-emergent adverse events were Grade 1 or 2.

"We are encouraged to see meaningful clinical benefit from STRO-002 for patients with advanced platinum-resistant and refractory ovarian cancer. The women on the study are heavily pretreated and have limited treatment options as many have received experimental agents and participated in other clinical trials," said Dr. Lainie Martin, an investigator on the STRO-002.

The stock rallied 20% to $20.40 in after-hours trading.

BioCryst Gets FDA Approval For Drug to Treat Inherited Swelling Disorder

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) said the FDA has approved oral, once-daily Orladeya, a plasma kallikrein inhibitor, for prophylaxis to prevent attacks of hereditary angioedema, or HAE, in adults and pediatric patients 12 years and older.

"ORLADEYO offers people with HAE and their physicians the first orally administered non-steroidal option for preventing HAE attacks and represents an important and welcome step in making more treatment options available to physicians and patients," said Anthony Castaldo, CEO of the US Hereditary Angioedema Association.

The stock was jumping 21.91% to $6.26 in premarket trading.

Moderna COVID-19 Vaccine Found Durable Up to 3 Months From Booster Dose, to Make Available 20M Doses By End-2020

Moderna Inc (NASDAQ: MRNA) said interim durability data from the NIH-led Phase 1 study of its coronavirus vaccine candidate – mRNA-1273 – showed that vaccinated people retained high levels of neutralizing antibodies through 119 days following first vaccination, or 90 days following second vaccination.

High levels of binding and neutralizing antibodies produced on vaccination with mRNA-1273 declined slightly over time, but remained elevated in all participants three months after the booster vaccination, Moderna said.

Moderna re-affirmed its expectation of having about 20 million doses available in the U.S. by the end of 2020. Additionally, the company expects to manufacture from 500 million to up to 1 billion doses globally, with 85 million to 100 million doses to be made available in the first quarter of 2021. Of the first quarter availability, 85 million to 100 million doses are to be made available in the U.S. and the remaining 15 million to 25 million doses outside of the U.S.

Clover Reports Positive Phase 1 Data For COVID-19 Vaccine Candidate Combined With GSK and Dynavax Adjuvants

Clover Biopharma, which is developing protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from GlaxoSmithKline plc (NYSE: GSK) or Dynavax Technologies Corporation (NASDAQ: DVAX), announced positive Phase 1 data. The vaccine candidate induced strong immune responses, including neutralizing antibodies and cell-mediated immunity, as well as favorable safety and tolerability profiles in 150 adult and elderly participants.

Based on the positive Phase 1 results, the company is planning to initiate a global Phase 2/3 efficacy study of the S-Trimer vaccine candidate in combination with GSK's pandemic adjuvant system in December, and a separate pivotal clinical trial of the S-Trimer vaccine candidate in combination with Dynavax's advanced CpG 1018 adjuvant plus alum in the first half of 2021.

In premarket trading Friday, Dynavax shares were up 0.39% to $5.19 and GlaxoSmithKline was edging up marginally to $37.30.

Cortexyme Says Alzheimer's Candidate Passes Futility Analysis

Cortexyme Inc (NASDAQ: CRTX) announced that the independent Data Monitoring Committee conducted a pre-planned interim analysis and recommended Cortexyme continue the Phase 2/3 GAIN trial of its Alzheimer's candidate atuzaginstat as planned to the 1-year endpoint. Top-line results are expected as planned in December 2021.

Takeda Antiviral Treatment Candidate Aces Late-Stage Study In Patients With Cytomegalovirus Infection

Takeda Pharmaceutical Co Ltd (NYSE: TAK) announced topline results from the Phase 3 SOLSTICE study evaluating the efficacy and safety of the investigational drug TAK-620, showing the trial met its primary endpoint, defined as the proportion of patients who achieved confirmed CMV viremia clearance compared to investigator-assigned treatment, or IAT, at the end of Study week 8.

The study also met its key secondary endpoint, defined as achievement of CMV viremia clearance and symptom control at end of week 8, and maintained through week 16. No new safety signals were identified and maribavir was associated with lower incidence of neutropenia compared to IAT.

On The Radar Clinical Readouts

Xenon Pharmaceuticals Inc (NASDAQ: XENE) is scheduled to present at the American Epilepsy Society, or AES, Annual Meeting, interim data from the Phase 2 proof-of-concept study evaluating XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant childhood absence epilepsy.

Ovid Therapeutics Inc (NASDAQ: OVID) will present at the AES meeting update on the TAK-935/OV935 clinical development program in Dravet syndrome or Lennox-Gastaut syndrome and Phase 2 data from the OV101 clinical development program in Angelman syndrome.

IPOs

Sigilon Therapeutics, a biotech that develops functional cures for chronic diseases through its Shielded Living Therapeutics platform, priced its upsized initial public offering, or IPO, of 7 million shares of its common stock at $18 per share, the mid-point of the estimated price range of $17-$19. The common stock of the Cambridge, Massachusetts-based biotech will begin trading on the Nasdaq under the symbol SGTX.

The gross proceeds of the offering are expected to be $126 million.The offering is expected to close on Dec. 8.

Seattle, Washington-based Silverback Therapeutics a clinical-stage oncology-focused biopharma, priced its upsized IPO of 11.5 million shares of its common stock at $21.00 per share, for raising gross proceeds of $241.5 million. The company had earlier estimated a price range of $19-$20.

Shares are expected to begin trading on the Nasdaq under the ticker symbol SBTX. The offering is expected to close Dec. 8.

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates

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