Pfizer teams with SpringWorks to evaluate PF‐06863135 + nirogacestat in multiple myeloma

• Pfizer (NYSE:PFE) has entered into a clinical trial collaboration agreement with SpringWorks Therapeutics (NASDAQ:SWTX) to evaluate the latter's investigational gamma secretase inhibitor (GSI), nirogacestat, in combination with Pfizer’s anti-B-cell maturation antigen (BCMA) CD3 bispecific antibody, PF‐06863135, in patients with relapsed or refractory multiple myeloma.
• Under the terms of the agreement, Pfizer will sponsor and conduct the Phase 1b/2 study to evaluate the safety, tolerability and preliminary efficacy of the combination, and will assume all costs associated with the study, other than expenses related to the manufacturing of nirogacestat and expenses related to intellectual property rights.
• Both the companies will also form a joint development committee to manage the clinical study, which is expected to commence in H1 2021.
• In addition, SpringWorks is also currently conducting a global Phase 3, double-blind, placebo-controlled clinical trial (the DeFi Trial) to evaluate nirogacestat in adults with progressing desmoid tumors.
• https://seekingalpha.com/news/3619700-pfizer-teams-up-springworks-to-evaluate-pf-06863135-nirogacestat-in-multiple-myeloma
  

Gilead's Biktarvy shows sustained long-term benefit in range of studies

• Gilead Sciences (NASDAQ:GILD) announces long-term results from switch studies and an analysis of real-world data that support the safety and efficacy of once-daily single-tablet Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF), approved in the U.S. in February 2018 for the treatment of adults with HIV-1 infection. The results were presented at HIV Glasgow.
• Patients who switched to Biktarvy from a boosted protease inhibitor-based regimen consisting of atazanavir or darunavir plus either emtricitabine/tenofovir disoproxil fumarate or abacavir /lamivudine maintained virologic suppression (defined as HIV-1 RNA <50 copies/mL) with no emergent resistance, through a maximum of 156 weeks.
• On the safety front, the most common drug-related adverse event was headache (2%).
• An analysis of pooled data from six studies assessing the efficacy of switching to Biktarvy among virologically suppressed people living with HIV who have the most common treatment-emergent resistance mutations (M184V/I) showed that 98% (n=179/182) maintained virologic suppression at the last study visit (weeks 24-156) with no emergence of treatment resistance.
• New findings from an open-label Phase 3b study showed that HIV-positive patients at least 65 years old who switched to Biktarvy from Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) or a TDF-based complete treatment regimen maintained high rates of virologic suppression, with no virologic failures or emergent resistance through week 72.
• Results from the real-world BICSTaR study showed that 100% (n=74/74) of treatment-naïve and 96 percent (n=357/372) of treatment-experienced participants who completed 12 months of treatment with Biktarvy maintained virologic suppression.
• https://seekingalpha.com/news/3619711-gileads-biktarvy-shows-sustained-long-term-benefit-in-range-of-studies
  

Kronos Bio sets IPO terms

• Kronos Bio (KRON) has filed an updated preliminary prospectus for an IPO of ~10.3M common shares at $16-18 per share.
• Net proceeds should be ~$159.3M at the midpoint.
• Underwriters' overallotment will be an additional ~1.54M shares.
• Net proceeds will be used to fund clinical trials, for development of SYK and CDK9 programs and other product candidates, for working capital and for other general corporate purposes.
• Previously: Kronos Bio on deck for IPO (Sept. 21)
• https://seekingalpha.com/news/3619710-kronos-bio-sets-ipo-terms
  

BridgeBio Pharma to acquire remaining 36.3% shares in Eidos

• BridgeBio Pharma (NASDAQ:BBIO) and Eidos Therapeutics (NASDAQ:EIDX) have entered into an agreement under which BridgeBio has agreed to acquire all of the outstanding common stock of Eidos it does not already own, representing ~36.3% of outstanding shares.
• Eidos stockholders will have the right to receive, either 1.85 shares of BridgeBio common stock or $73.26 in cash per Eidos share up to an aggregate maximum of $175M of cash.
• BridgeBio will be able to invest in novel formulations and studies of acoramidis to maximize its long-term potential benefit to ATTR patients, as well as developing its commercial infrastructure.
• Eidos completed screening in September for its Phase 3 ATTRibute-CM clinical trial of acoramidis in patients with ATTR cardiomyopathy. The study is expected to enroll more than 600 subjects with either wild-type or variant TTR across more than 80 sites in 18 countries.
• Topline results from Part A are expected in late 2021 or early 2022 and from Part B in 2023. If Part A is successful, the company intends to file for regulatory approval of acoramidis in 2022.
• BridgeBio expects to launch two drugs, if approved, in 2021.
• The transaction is expected to close in Q1 2021.
• Upon closing, Eidos will become a wholly owned subsidiary of BridgeBio and Eidos’ common stock will cease trading independently on Nasdaq.
• https://seekingalpha.com/news/3619723-bridgebio-pharma-to-acquire-remaining-36_3-shares-in-eidos-therapeutics
  

ViiV HIV doublet therapy on par with triplet in previously untreated adults

• Three year data from the Phase 3 GEMINI 1 and GEMINI 2 studies evaluating ViiV Healthcare's two-drug regimen of dolutegravir and lamivudine (branded as Dovato) showed it to be non-inferior (no worse than) to the three-drug regimen of dolutegravir plus two nucleoside reverse transcriptase inhibitors, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment-naïve adults with HIV-1. The results were presented at HIV Glasgow.
• On the treatment resistance front, only 1.7% (n=12/716) of patients experienced confirmed virologic withdrawal compared to 1.3% (n=9/717) in the dolutegravir + TDF/FTC group. None developed treatment-emergent resistance mutations.
• The FDA approved Dovato in April 2019 for treatment-naïve adults with HIV-1.
• ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (NYSE:GSK) (+1%), Pfizer (NYSE:PFE) (+1%) and Shionogi (OTCPK:SGIOY).
• https://seekingalpha.com/news/3619720-viiv-hiv-doublet-therapy-on-par-triplet-in-previously-untreated-adults
  

NeoPhotonics raises Q3 outlook

• NeoPhotonics (NYSE:NPTN) reports Q3 revenue of $101-103M (prior: $97-105M), adjusted EPS of $0.10-0.14 (prior: $0.03-0.13), and adjusted gross margin of 32-34% (prior: 30-34%).
• As previously announced, the company has adopted a "conservative approach" to exclude Huawei contributions from the outlook due to the August 17 tightening of the U.S. actions against the company.
• The company has tightened production operations, consolidated Iridium Phosphide production, and implemented a 4% workforce reduction.
• The actions should add $12.1M in costs, which will mostly be recognized in Q3.
• https://seekingalpha.com/news/3619733-neophotonics-raises-q3-outlook
  

Senseonics files U.S. application to extend wearable life of glucose monitor

• Senseonics (NYSEMKT:SENS) has filed a supplemental marketing application in the U.S. seeking approval to extend the wearable life of the Eversense CGM System to 180 days from the current 90 days.
• The company says the next-generation system features an improved algorithm and reduced calibration scheme, requiring only one per day.
• If approved, partner Ascensia Diabetes Care will distribute.
• https://seekingalpha.com/news/3619729-senseonics-files-u-s-application-to-extend-wearable-life-of-glucose-monitor