BPC August 31 update

AC Immune ACIU mixed Phase 2 results for Alzheimer’s drug +16%; Poseida Therapeutics PSTX preliminary Phase 1 data -19%

Price and Volume Movers

AC Immune SA. (NASDAQ: ACIU) released data for its Phase 2 trial of semorinemab to treat Alzheimer’s disease. The trial met one of its two co-primary endpoints. AC Immune noted that further analyses are ongoing, and top-line data will be submitted for presentation at the CTAD conference (Clinical Trials on Alzheimer's Disease) in November 2021. Shares closed up 16% at $8.31.

Qualigen Therapeutics (NASDAQ: QLGN) shares closed up 23% to $1.57 after Zacks Small-Cap Research set a $9 valuation on the stock. Qualigen shares hit a 52-week low on August 20th.

Poseida Therapeutics (NASDAQ: PSTX) announced preliminary results from its Phase 1 trial of P-PSMA-101 in patients with metastatic cas­trate-re­sis­tant prostate can­cer (mCRPC). Of the nine patients, three showed a greater than 50% drop in PSA lev­els with one patient displaying a complete tumor elimination. Following the data release, shares dropped, closing the day down 19% at $8.64.

VectivBio Holding AG (NASDAQ: VECT) announced the acquisition of Comet Therapeutics, a privately held company developing drugs to address Inherited Metabolic Diseases. This acquisition will expand VectivBio's rare disease pipeline. Shares closed up 18% to $8.49.

Ascendis Pharma A/S (NASDAQ: ASND) announced that it has commenced an underwritten public offering for $400 million of American Depositary Shares, each of which represents one ordinary share of Ascendis. Shares are currently trading after hours down 4% to $151.11.

Advancers

CompanyPriceChange
CRVS
Corvus Pharmaceuticals Inc.
$5.32+3.06  +135.40%
IPHA
Innate Pharma S.A.
$8.10+2.35  +40.87%
CYDY
Cytodyn Inc
$2.01+0.37  +22.56%
SURF
Surface Oncology Inc.
$7.10+1.09  +18.14%
ATNM
Actinium Pharmaceuticals Inc. (Delaware)
$7.83+1.15  +17.22%
EVLO
Evelo Biosciences Inc.
$8.34+1.03  +14.09%
MGTA
Magenta Therapeutics Inc.
$7.79+0.92  +13.39%
CNTB
Connect Biopharma Holdings Limited
$23.06+2.51  +12.21%
TRVN
Trevena Inc.
$1.36+0.14  +11.48%
FULC
Fulcrum Therapeutics Inc.
$30.83+3.14  +11.34%

Decliners

CompanyPriceChange
PTGX
Protagonist Therapeutics Inc.
$17.53-28.6  -62.00%
TCRR
TCR2 Therapeutics Inc.
$9.99-5.73  -36.45%
ELYM
Eliem Therapeutics Inc
$18.77-5.27  -21.92%
JANX
Janux Therapeutics Inc.
$27.39-6.96  -20.26%
ICVX
Icosavax Inc.
$33.06-6.4  -16.22%
IPSC
Century Therapeutics Inc.
$24.76-4.49  -15.35%
GRTS
Gritstone bio Inc.
$11.50-2.04  -15.07%
VERV
Verve Therapeutics Inc.
$59.88-9.99  -14.30%
INAB
IN8bio Inc.
$7.00-1.09  -13.47%
TNYA
Tenaya Therapeutics Inc.
$20.85-3.2  -13.31%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ACIU – AC Immune SA
Semorinemab (LAURIET)
Alzheimer’s disease

$6.99
+0.12  +2%
Phase 2 Phase 2 top-line data met one of two co-primary endpoints August 31, 2021. Top-line results to be presented at CTAD November 9-12, 2021.
$507.8 million

ANIP – ANI Pharmaceuticals Inc.
Cortrophin Gel
Acute exacerbations of multiple sclerosis, rheumatoid arthritis, systemic lupus erythematous and ulcerative colitis

$28.89
+0.91  +3%
PDUFA Refusal to File (RTF) letter announced April 29, 2020. sNDA resubmitted with PDUFA date of October 29, 2021.
$368.4 million

CNTB – Connect Biopharma Holdings Limited
CBP-201
Atopic dermatitis

$23.06
+2.51  +12%
Phase 2b Phase 2b top-line data due 4Q 2021.
$1.3 billion

CNTB – Connect Biopharma Holdings Limited
CBP-307
Ulcerative Colitis

$23.06
+2.51  +12%
Phase 2b Phase 2b top-line data expected 1Q 2022.
$1.3 billion

CYTK – Cytokinetics Incorporated
Aficamten - Redwood-HCM
Hypertrophic cardiomyopathy (HCM)

$33.89
+0.40  +1%
Phase 2 Phase 2 full trial data resulted in statistically significant reductions from baseline compared to placebo in the average resting left ventricular (LV) outflow tract pressure gradient and the average post-Valsalva. The observed reductions in LVOT-G were dose dependent. Patients treated with aficamten in both Cohort 1 and Cohort 2 also experienced statistically significant reductions in NT-proBNP, noted September 12, 2021. Phase 3 trial to commence in 2021.
$2.8 billion

IMAB – I-MAB
Felzartamab (TJ202/MOR202)
Third-line multiple myeloma

$75.85
+7.71  +11%
BLA Filing BLA submission in 4Q 2021
$5.7 billion

IMAB – I-MAB
Lemzoparlimab (TJC4) and KEYTRUDA (pembrolizumab)
Solid tumor, Lymphoma

$75.85
+7.71  +11%
Phase 1b Phase 1b initial data expected by the end of 2021 or early 2022.
$5.7 billion

JNJ – Johnson & Johnson
HVTN 705/HPX2008 (Imbokodo)
HIV in Women

$164.75
-0.47  -0%
Phase 2b Phase 2b data did not meet endpoints, study will not continue - August 31, 2021.
$433.7 billion

JNJ – Johnson & Johnson
HVTN 706/HPX3002 (Mosaico)
HIV in MSM and Transgender

$164.75
-0.47  -0%
Phase 3 Phase 3 initial finding expected in 2023.
$433.7 billion

MRK – Merck & Company Inc.
KEYTRUDA (pembrolizumab) - KN-361
Bladder cancer

$71.68
-0.29  -0%
Approved FDA approval announced August 31, 2021.
$181.4 billion

TEVA – Teva Pharmaceutical Industries Limited American Depositary Shares
Risperidone
Schizophrenia

$8.99
+0.04  +0%
PDUFA NDA accepted by FDA August 31, 2021. Estimated PDUFA June 30, 2022 based on a 10-month timeline following NDA acceptance.
$9.9 billion