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The Daily Biotech Pulse: Ardelyx Awaits Ruling On Constipation Drug, Double Dose Of Good News For Roche, Tocagen Flunks Brain Cancer Study

Shanthi Rexaline

The following is a roundup of top developments in the biotech space over the last 24 hours. 

Scaling The Peaks

(Biotech stocks that hit 52-week highs Sept. 11.)

  • Avedro Inc (NASDAQ: AVDR)
  • Catalyst Pharmaceuticals Inc (NASDAQ: CPRX)
  • Nevro Corp (NYSE: NVRO)

Down In The Dumps

(Biotech stocks that hit 52-week lows Sept. 11.)

  • Karuna Therapeutics Inc (NASDAQ: KRTX)

Stocks In Focus Roche Reports Positive Results For Two Drugs 

Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY) announced full results from a pivotal Phase 3 study of satralizumab as a monotherapy for neuromyelitis optica spectrum disorder, or NMOSD, which showed that the investigational compound achieved a 55% reduction in the risk of relapses compared to placebo.

The results were presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis being held in Stockholm, Sweden.

In the large subgroup of patients seropositive for AQP4-IgG antibodies, a 74% reduction in the risk of relapses occurred.

Satralizumab is being developed by Japan's CHUGAI PHARMACE/ADR (OTC: CHGCY), which is majority-owned by Roche.

Both companies said they plan to file global regulatory applications this year.

Separately, Roche reported positive results for its Phase 3 Impower110 study that evaluated Tecentriq as a first-line monotherapy compared with chemotherapy in advanced non-squamous, non-small cell lung cancer patients without ALK, or EGFR mutations.

See also: Biotech Stock On The Radar: Aimmune Awaits Adcom Test

Tocagen's Brain Cancer Study Fails To Meet Primary, Secondary Endpoints

Tocagen Inc (NASDAQ: TOCA) said the Phase 3 TOCA 5 study evaluating Toca 511 and Toca FC in patients with recurrent, high-grade glioma undergoing resection missed the primary endpoint of overall survival compared to the standard of care. The secondary endpoints also did not show meaningful difference between the arms of the trial.

Tocagen shares were plunging 80.62% to 81 cents at the time of publication in Thursday's premarket session. 

Moderna Reports Positive Phase 1 Results For mRNA Vaccine

Moderna Inc (NASDAQ: MRNA) announced positive results from the three-month interim analysis of safety and immunogenicity of the Phase 1 study of its investigational cytomegalovirus, or CMV, vaccine mRNA-1647.

Moderna said it is advancing mRNA-1647 to a dose-confirmation Phase 2 study in the near term.

Offerings Catalyst Pharma

Catalyst Pharma announced the commencement of an underwritten public offering of 8 million shares of its common stock. All the shares are to be offered by the company.

The company said it intends to use the net proceeds from the offering to continue commercialization of Firdapse, to fund business expansion activities in the U.S. and Japan and for general corporate purposes.

The stock was down 11.17% at $6.60 in Thursday's premarket session. 

Apellis Pharmaceuticals Inc (NASDAQ: APLS) said it intends to offer, subject to market and other conditions, a $200 million aggregate principal amount of convertible senior notes due 2026 in a private offering to qualified institutional buyers.

The company said it intends to use the net proceeds to pay the cost of the capped call transactions and to fund the clinical development of its APL-2.

The stock was falling 4.31% to $30.21 in Thursday's premarket session. 

Fate Therapeutics Inc (NASDAQ: FATE) said it has commenced an underwritten public offering of its common stock, with the company seeking to use the net proceeds for purposes such as the funding of clinical trials and non-clinical studies and the manufacturing of clinical product candidates.

The stock was slipping 3.48% to $17.75 at the time of publication Thursday. 

On The Radar PDUFA Dates

The FDA is set to rule on Ardelyx Inc (NASDAQ: ARDX)'s NDA for tenapanor in treating irritable bowel syndrome with constipation.

Clinical Trial Readouts

TG Therapeutics Inc (NASDAQ: TGTX) is due to present Phase 2 long-term follow-up data for TG-1101 in a relapsing form of multiple sclerosis at the ECTRIMS Congress.

Adverum Biotechnologies Inc (NASDAQ: ADVM) is due to release 24-week data from the first cohort in a Phase 1 study evaluating its ADVM-022 in wet age-related macular degeneration.

IPOs

10x Genomics, a provider of a single-cell sequencing platform for biomedical research, priced its upsized offering of 10 million shares at $39, above the previously estimated price range of $31-$35. The company's shares are to be listed on the Nasdaq under the ticker symbol "TXG."

Related Link: The Week Ahead In Biotech: Focus On Earnings Deluge, Mid-Year Clinical Trial Readouts

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