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The Daily Biotech Pulse: Spectrum's Positive Dementia Readout, Pfizer, BioNTech Start Late-Stage Coronavirus Trial, resTORbio Receives COVID-19 Funding

Shanthi Rexaline
·8 min read

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs July 27)

  • Arcturus Therapeutics Holdings Inc (NASDAQ: ARCT)

  • Bio-Rad Laboratories, Inc. Class B Common Stock (NYSE: BIO)

  • Fulgent Genetics Inc (NASDAQ: FLGT)

  • Genocea Biosciences Inc (NASDAQ: GNCA)

  • Inozyme Pharma Inc (NASDAQ: INZY) (went public Friday)

  • ITAMAR MED LTD/S ADR (NASDAQ: ITMR)

  • MediciNova, Inc. (NASDAQ: MNOV) (announced an agreement with BioComoor to jointly develop a SARS-CoV-2 vaccine)

  • Mediwound Ltd (NASDAQ: MDWD)

  • Nurix Therapeutics Inc (NASDAQ: NRIX) (went public Friday)

  • Penumbra Inc (NYSE: PEN)

  • Qiagen NV (NYSE: QGEN)

  • RENALYTIX AI ADR (NASDAQ: RNLX)

  • Trevena Inc (NASDAQ: TRVN)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 27)

  • Annexon Inc (NASDAQ: ANNX) (went public Friday)

  • Fusion Pharmaceuticals Inc (NASDAQ: FUSN)

  • Happiness Biotech Group Ltd (NASDAQ: HAPP)

  • Immatics NV (NASDAQ: IMTX)

  • Nkarta Inc (NASDAQ: NKTX)

  • ORIC Pharmaceuticals Inc (NASDAQ: ORIC)

  • Psychemedics Corp. (NASDAQ: PMD)

  • Repare Therapeutics Inc (NASDAQ: RPTX)

  • Tricida Inc (NASDAQ: TCDA)

  • Verrica Pharmaceuticals Inc (NASDAQ: VRCA)

Stocks In Focus Spectrum's Cancer Drug Meets Primary Endpoint In Late-Stage Registrational Trial

Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) announced that its ZENITH20 Phase 2 clinical trial evaluating poziotinib in previously treated non-small cell lung cancer patients with HER2 exon 20 insertion mutations, enrolled in Cohort 2, met the pre-specified primary endpoint.

The intent-to-treat analysis demonstrated a confirmed objective response rate of 27.8%, the company said. The median duration of response was 5.1 months, with a median follow up of 8.3 months. The disease control rate was 70% and the median progression-free survival was 5.5 months.

On safety, the company said the safety profile was in line with the type of adverse events seen with other second-generation EGFR tyrosine kinase inhibitors and similar to Cohort 1.

"There are currently no approved therapies for HER2 patients with exon 20 insertion mutations in NSCLC and we are looking forward to reviewing this data with the FDA to determine the path forward," said Francois Lebel, Spectrum's chief medical officer. 

The company said it is in the process of requesting a meeting with the FDA to discuss the data and its plans for a NDA submission.

The stock was jumping 50.93% to $4.89 premarket Tuesday.

Lumos To Sell Priority Review Voucher To Merck For $60M

Lumos Pharma Inc (NASDAQ: LUMO) said it has entered into a definitive agreement to sell its Priority Review Voucher to Merck & Co., Inc. (NYSE: MRK).

The PRV was granted in conjunction with the FDA approval of Ervebo, a vaccine developed by its licensee, Merck, for the prevention of the Ebola virus disease.

Under the terms of the original license agreement, Lumos Pharma is entitled to retain 60% of the value of the PRV. Based upon an agreed valuation of $100 million, Merck will now pay Lumos $60 million.

The stock was up 9.79% at $16.26 premarket.

Pfizer, BioNTech Finalize Coronavirus Vaccine Candidate, Start Phase 2/3 Study

Close on the heels of Moderna Inc (NASDAQ: MRNA) initiating a late-stage study of its coronavirus vaccine candidate, Pfizer Inc. (NYSE: PFE) and BioNTech SE – ADR (NASDAQ: BNTX) announced the start of a global Phase 2/3 safety and efficacy study to evaluate a single nucleoside-modified.

The companies said they have decided to advance their BNT162b2 vaccine candidate into the Phase 2/3 study at 30mcg dose levels in a two-dose regimen.

Separately, Pfizer reported forecast-beating results for its second quarter and raised its 2020 guidance.

Pfizer shares were up 3.6% at $38.89 premarket, while BioNTech shares were higher by 3.6% at $38.89.

See also: The Week Ahead In Biotech: Spotlight On GW Pharma, Ultragenyx FDA Decisions, Pfizer Earnings

Reata Announces Investigator-Sponsored Study Of COVID-19 Drug

Reata Pharmaceuticals Inc (NASDAQ: RETA) said researchers at NYU Grossman School of Medicine are initiating an investigator-sponsored trial dubbed BARCONA to study the effect of bardoxolone methyl in patients suffering from COVID-19.

The company said it is providing drug supply for the trial and NYU will initiate the Phase 2 study with a primary endpoint of safety.

Prevail Awarded Composition Of Matter Patent For Dementia Gene Therapy Candidate

Prevail Therapeutics Inc (NASDAQ: PRVL) said the U.S. Patent and Trademark Office on June 23 issued a composition of matter patent, with claims directed to the AAV vector used in PR006, its experimental gene therapy program for the treatment of frontotemporal dementia patients with GRN mutations.

The base patent term extends until October 2038, excluding patent term extensions or coverage in additional related patent filings, the company said.

In after-hours trading, the stock added 3.34% to $16.69.

resTORbio Announces National Institute On Aging Funding For COVID-19 Study

resTORbio, Inc. (NASDAQ: TORC) said the National Institute on Aging has agreed to fund a randomized, double-blind, placebo-controlled pilot study of RTB101, an investigational, orally administered potent small molecule inhibitor of target of rapamycin complex 1, as compared to placebo for COVID-19 post-exposure prophylaxis in older adults.

The study is supported by additional data observed in resTORbio's Phase 2b and Phase 3 clinical trials, which suggest the potential of RTB101 to reduce the severity of laboratory-confirmed coronavirus infections as previously announced, the company said.

View more earnings on IBB

The stock was advancing 10.32% to $2.78 premarket Tuesday.

AstraZeneca's Diabetes Drug Aces Late-Stage Study In Kidney Disease

AstraZeneca plc (NYSE: AZN) said FARXIGA significantly reduced the worsening of renal function or risk of death in patients with chronic kidney disease with and without Type 2 diabetes in a Phase 3 trial.

Earnings

Medpace Holdings Inc (NASDAQ: MEDP) reported second-quarter revenue that fell 4.3% to $205 million, and GAAP net income fell from 73 cents per share to 64 cents per share.

The company guided to full-year revenue of $880 million to $920 million and EPS of $3.62-$3.83. Analysts, on average, estimate revenue of $839.49 million and EPS of $2.56.

The stock was up 11.29% at $125 premarket Tuesday.

Crispr Therapeutics AG's (NASDAQ: CRSP) second-quarter collaboration revenues fell from $300,000 in 2019 to $100,000 in 2020. The net loss per share widened from $1.01 to $1.30. Analysts had estimated a loss for 95 cents for the quarter.

The stock lost 5.18% to $87.35 premarket Tuesday.

Offerings

Allena Pharmaceuticals Inc (NASDAQ: ALNA) said it has entered into an underwriting agreement with H.C. Wainwright & Co., under which the underwriter has agreed to purchase on a firm commitment basis 5.125 million shares of its common stock at a price to the public of $1.30 per share, for gross proceeds of $6.7 million.

The stock was slipping 16.23% to $1.29 premarket. 

Nemaura Medical Inc (NASDAQ: NMRD) said it intends to offer for sale shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering.

The stock was down 21.81% at $7.24 premarket.

BioXcel Therapeutics Inc (NASDAQ: BTAI) said it has commenced an underwritten public offering of $200 million in shares of its common stock.

The company said it intends to use the net proceeds of this offering to fund ongoing clinical trials, commercialization preparation and for general corporate purposes.

The stock was down 2.91% at $56.69 premarket Tuesday.

Zentalis Pharmaceuticals Inc Inc (NASDAQ: ZNTL) announced the commencement of a proposed underwritten public offering of 3.75 million shares of its common stock. All the shares are being offered by the company.

CorMedix Inc. (NYSE: CRMD) said it plans to offer shares of its common stock in an underwritten public offering. The company plans to use the net proceeds for general corporate purposes, including obtaining regulatory approval and commercialization of Defencath in the U.S., R&D, and working capital and capital expenditures.

The stock was down 13.17% at $5.21 premarket.

Tcr2 Therapeutics Inc (NASDAQ: TCRR) said it has commenced an underwritten public offering of 6 million shares of its common stock. The company intends to use the net proceeds of the offering to advance its clinical and earlier stage programs and for R&D, working capital and general corporate purposes.

The stock was up 4.33% at $17.10 premarket.

On The Radar Clinical Readouts

Alector Inc (NASDAQ: ALEC) will present at the Alzheimer's Association International Conference, or AAIC, preliminary data from a Phase 2 open-label study evaluating AL001 in individuals with frontotemporal dementia.

vTv Therapeutics Inc (NASDAQ: VTVT) is due to present at the AAIC analysis of already-released Phase 3 data for Azeliragon in mild Alzheimer's disease.

Earnings

  • Exagen Inc (NASDAQ: XGN) (before the market open)

  • Pfizer (reported Q2 revenue of $11.8 billion and adjusted EPS of 78 cents vs. consensus estimate of $11.55 billion and 66 cents, and raised FY20 guidance)

  • Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) (before the market open)

  • Masimo Corporation (NASDAQ: MASI) (after the close)

  • AtriCure Inc. (NASDAQ: ATRC) (after the close)

  • Amgen, Inc. (NASDAQ: AMGN) (after the close)

  • NeoGenomics, Inc. (NASDAQ: NEO) (after the close)

  • DexCom, Inc. (NASDAQ: DXCM) (after the close)

  • Infinity Pharmaceuticals Inc. (NASDAQ: INFI) (after the close)

Related Link: Pfizer Analyst Says COVID-19-Driven Rally Not Backed By Vaccine Economics

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