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Calithera Biosciences, Inc. (CALA)

NasdaqGS - NasdaqGS Real Time Price. Currency in USD
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0.7964+0.0184 (+2.37%)
As of 01:22PM EST. Market open.
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  • S
    Skydiver
    OMG!!! CALA up two days in a row. Can I stand the shock?
  • J
    Jim
    Calithera is a clear example of what happens when a CEO’s interests are not aligned with shareholders interests. Shareholders are interested in making money, Molineaux has plenty of money and her interest with Calithera is to make a difference. Had her interests been aligned properly, she would’ve sold the company when she had the chance but her ego wouldn’t allow it.
    Now, shareholders are left with nothing.
  • E
    Ed
    Has this company ever been successful with anything they work on?
  • S
    Shirley
    Generally the micro to small CAP biotechs have been getting "beat up" across the boards for weeks to months; really a shame for so many promising companies and shareholders (now bag holders -- at least for now).....
  • S
    Skydiver
    When CALA trends up every day for a week, like it's been doing down every day for months; then we will talk.
  • F
    Faris
    solid presentation, 74.12M outstanding shares, 94M in cash, over 6M volume. we could see this over 1.25 by the end of the day. Like if you agree
  • B
    Bruno
    The Takeda drug acquisitions discussed as to why.

    Calithera buys itself a plan B
    https://www.google.com/amp/s/www.evaluate.com/node/17301/amp
  • J
    Jim
    Shareholders are in serious trouble here. Management will have a very difficult time raising capital in light of past clinical performances, strategic blunders and their history of poor shareholder relations.
    They will get someone to bite, but the cost to long-time shareholders will be irreparable.
    Management really has no clue what they are doing outside the lab, and even that is questionable at this point.
  • B
    Bruno
  • M
    Mail
    Calithera Presents Interim Data from Phase 1b Trial of Arginase Inhibitor CB-280 in Cystic Fibrosis at NACFC 2021

    Calithera Biosciences, Inc.
    Mon, November 1, 2021, 7:00 AM
    In this article:

    -- CB-280 was well-tolerated, showed linear PK and demonstrated robust dose-related PD effects
    -- Encouraging trends seen in disease biomarkers including increased FeNO and decreased sweat chloride
    -- Early positive trend seen in FEV1, a safety endpoint

    SOUTH SAN FRANCISCO, Calif., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biopharmaceutical company, today shared interim safety and efficacy results from a Phase 1b, randomized, double-blind, placebo-controlled, dose-escalation trial evaluating CB-280, the company’s investigational arginase inhibitor, in adults with cystic fibrosis (CF). The data were shared in a poster presentation at the North American Cystic Fibrosis Foundation Conference (NACFC; Abstract 529).

    “There remains a high unmet need for novel anti-infective treatment approaches for people with cystic fibrosis,” said Susan Molineaux, Ph.D., president and chief executive officer of Calithera. “It’s incredibly rewarding to share these first clinical data from our CB-280 program, which further validate the compound’s novel mechanism of action, as well as its potential to become a new therapeutic option for all people with CF, regardless of the disease genotype.”

    CF is a genetic disease that causes persistent lung infections, resulting in progressive impairment of lung function over time. Research in CF patients has demonstrated that increased arginase activity correlates directly with worsened lung function and decreased airway nitric oxide (NO), promoting pathogen colonization. CB-280, a selective, orally dosed arginase inhibitor, is a novel, first-in-class approach to enhance airway NO levels to combat chronic airway infections and improve lung function in people with CF.

    At NACFC, data were presented on the first 24 subjects (18 treated with CB-280, six with placebo) participating in the ongoing, Phase 1b dose-escalation trial in adults with CF. Key eligibility criteria for patients included chronic lung infection and current treatment with a stable CF medication regimen including cystic fibrosis transmembrane conductance regulator (CFTR) modulators. Each dose cohort consisted of eight subjects randomized 3:1 to CB-280 or placebo dosed twice daily for 14 days. At the completion of each dose cohort, unblinded data were reviewed by an Independent Data Safety Monitoring Committee (IDMC) convened by the Cystic Fibrosis Foundation (CFF).

    Data were presented for 50mg BID, 100mg BID and 200mg BID dose levels. The study enrolled subjects with a broad spectrum of CFTR genotypes, including nonsense mutations. Notably, 91% of subjects were already on CFTR modulator therapy with Trikafta® (elexacaftor/tezacaftor/ivacaftor) or Kalydeco®(ivacaftor). CB-280 had a well-tolerated safety profile across all three dose levels, and all 18 subjects receiving CB-280 completed treatment without treatment interruptions or premature discontinuations. Changes in forced expiratory volume in one second (FEV1) were assessed as a safety endpoint. A pooled analysis of treatment vs. placebo showed a positive trend in FEV1 compared to placebo.

    CB-280 demonstrated linear pharmacokinetics with plasma exposure increasing proportionally with dose. Complete and continuous target inhibition in plasma was achieved at the 100 mg dose and above. CB-280 also demonstrated robust pharmacodynamic effects, with rapid and significant dose-proportional increases in plasma arginine, the key driver of NO production.

    Biomarkers of arginase inhibition showed trends that further substantiate the proposed mechanism of action. There was a trend toward increased FeNO and decreased sweat chloride in CB-280 treated subjects. Changes in sweat chloride were measured as an exploratory endpoint, based on published data showing enhanced CFTR function with arginase inhibition in human bronchial epithelial cells.

    “I am encouraged by these initial data of CB-280 in subjects with CF and chronic infection, particularly its well-tolerated safety profile and positive early trends in important disease markers including FeNO, FEV1, and sweat chloride,” said Scott Donaldson, M.D., Hubert E. Hatcher Distinguished Professor of Medicine, Division of Pulmonary Diseases and Critical Care Medicine, University of North Carolina, Chapel Hill, NC and a study investigator. “Although early, seeing such trends with a short dosing duration in subjects already on CFTR modulators, and across different CF disease genotypes is noteworthy. I look forward to expanding our understanding of this investigational, novel arginase inhibitor through this ongoing trial.”

    The study is ongoing with Cohort 4 (300mg BID) on track to complete enrollment by the end of 2021.

    A recorded presentation of the poster, “A phase 1b, randomized, double-blind, pl
  • w
    wallstreetbets
    (BEAT) $4.10...MCap 31 m..Float 2 m ..Blockbuster Product =1000% UPSIDE
  • S
    Skydiver
    The price simply deteriorates day after day without trend change.
  • B
    Bruno
    Bruno on Calithera Biosciences

    I don't want to lend crediibility to the broader market, but it appears that common sense is returning to the forefront with the removal of traders from this issue and the exit of Weak Hands which indicates a continued modest share price recovery in the near term.
  • E
    Ed
    They should be so proud of their share price.
  • k
    kotonk
    Starting to come back from the 52-week low? I knew it wasn't going to stay down there for long.
  • P
    Plantigenous
    Got in at 1.92. :(

    Hopefully there is a big surprise to look forward before EOY. Would like to see at least 1.20 by then.
    Neutral
  • F
    Faris
  • B
    Barren1925
    bought a truck load at .83
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