BPC October 08 update

ChemoCentryx CCXI +96% Approval; Agile AGRX -28% Offering

Price and Volume Movers

ChemoCentryx, Inc. (NASDAQ: CCXI) announced that the FDA approved TAVNEOS (avacopan) to treat ANCA-associated vasculitis (AAV). Shares closed the day up 96% at $38.41.

Agile Therapeutics, Inc. (NASDAQ: AGRX) announced a public offering of its common stock at $0.85 per share and one-half of a warrant to purchase one share of common stock. The gross proceeds are to be approximately $22,666,650. Shares closed down 28% at $0.67.

Repare Therapeutics Inc. (NASDAQ: RPTX) presented preliminary results from its Phase 1/2 clinical trial of RP-3500 to treat solid tumors. Data noted that a “meaningful” clinical benefit was observed in 49% of 69 patients; including 12 patients with tumor responses, 14 reported stable disease (SD) for 16 weeks, and 8 patients with SD but had demonstrated significant decreases in tumor markers and tumor shrinkage of less than 30%. Shares closed down 7% at $20.46.

Cognition Therapeutics, Inc. (NASDAQ: CGTX) commenced trading after its initial public offering (IPO) today. The public offering price was at $12.00 per share, and the gross proceeds are to be approximately $45.2 million. Shares closed up 6% at $12.77.

Pyxis Oncology, Inc. (NASDAQ: PYXS) started trading after its initial public offering (IPO) today. The public offering price was at $16.00 per share, and the gross proceeds are to be approximately $168.0 million. Shares closed down 17% at $13.20.

Advancers

CompanyPriceChange
PROG
Progenity Inc.
$2.87+0.36  +14.60%
ATHA
Athira Pharma Inc.
$10.69+1.06  +11.01%
CNTX
Context Therapeutics Inc.
$6.69+0.52  +8.43%
CABA
Cabaletta Bio Inc.
$13.97+1.02  +7.92%
RPTX
Repare Therapeutics Inc.
$24.54+1.77  +7.80%
CMPS
COMPASS Pathways Plc
$38.03+2.72  +7.70%
BFRA
Biofrontera AG
$5.90+0.4  +7.18%
KALA
Kala Pharmaceuticals Inc.
$2.03+0.13  +6.84%
PTPI
Petros Pharmaceuticals Inc.
$1.81+0.11  +6.47%
TYRA
Tyra Biosciences Inc.
$22.74+1.27  +5.92%

Decliners

CompanyPriceChange
MTCR
Metacrine Inc.
$1.61-2.22  -57.96%
OCUL
Ocular Therapeutix Inc.
$6.96-3.87  -35.75%
AGEN
Agenus Inc.
$3.88-1.25  -24.27%
STAB
Statera Biopharma Inc.
$3.31-0.56  -14.60%
SIOX
Sio Gene Therapies Inc.
$2.04-0.32  -13.69%
CNTB
Connect Biopharma Holdings Limited
$15.41-2.26  -12.79%
ICVX
Icosavax Inc.
$25.04-3.04  -10.83%
APLT
Applied Therapeutics Inc.
$14.01-1.68  -10.71%
XFOR
X4 Pharmaceuticals Inc.
$4.43-0.52  -10.51%
RNLX
Renalytix AI plc
$24.54-2.86  -10.44%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

AMGN – Amgen Inc.
Tezepelumab
Eosinophilic esophagitis (EoE)

$209.62
+0.63  +0%
Phase 3 Phase 3 trial is planned.
$119 billion

ARGX – argenx SE
Efgartigimod (ADAPTsc)
Generalized Myasthenia Gravis

$291.87
-2.30  -1%
Phase 3 Phase 3 data due 1H 2022
$15 billion

CCXI – ChemoCentryx Inc.
TAVNEOS (avacopan)
Associated vasculitis (AAV)

$33.92
-1.09  -3%
Approved FDA approval announced October 8, 2021.
$2.4 billion

FBIO – Fortress Biotech Inc.
CUTX-101
Menkes disease

$2.98
-0.06  -2%
NDA Filing Rolling NDA submission expected to start in 4Q 2021. Phase 1/2 trial data showed that the primary efficacy endpoint comparing CuHis-ET to HC-ET and the secondary efficacy endpoint comparing CuHis-LT to HC-LT were both met. Overall, a 79% reduction in risk of death was observed in CuHis-ET patients compared with HC-ET patients and median OS was 177.1 and 16.1 months, respectively with a hazard ratio (HR) of 0.208, noted October 8, 2021. Phase 1/2 data from both pre-specified primary and secondary efficacy analyses showed treatment with CUTX-101 demonstrated a significantly greater median overall survival (OS) compared to untreated historical control patients, noted October 14, 2021.
$301.7 million

RHHBY – Roche Holding AG ADR
Gantenerumab - (GRADUATE)
Early Alzheimer's disease

$48.53
-0.31  -1%
Phase 3 Phase 3 enrollment has commenced - noted June 14, 2018. Breakthrough Therapy Designation announced October 8, 2021. Phase 3 data due 2H 2022.
$331.7 billion

RLAY – Relay Therapeutics Inc.
RLY-4008
Solid tumors

$31.76
+0.51  +2%
Phase 1 Phase 1 interim data demonstrated tumor shrinkage in all pan-FGFR treatment-naïve FGFR2 fusion positive cholangiocarcinoma patients with 3/6 achieving confirmed PR with deep tumor regressions (-56% to -83%), and 3/6 patients continuing on treatment and a fourth who went on to surgery with curative intent. Approximately 80% of all patients treated achieved radiographic tumor regressions across all dose levels, noted October 8, 2021. Expansion cohorts to be initiated before the end 2021. Phase 1 ongoing first-in-human study data update expected 2022.
$3.4 billion

RPTX – Repare Therapeutics Inc.
RP-3500 (TRESR)
Solid tumors

$24.54
+1.77  +8%
Phase 1/2 Phase 1/2 dosing of first patient announced July 29, 2020. Phase 1/2 data noted treatment appears safe and well tolerated. Clinical benefit was observed in 49% of 69 patients, including 12 patients with tumor responses per established international efficacy criteria, 14 reported stable disease (SD) for 16 weeks and 8 patients with SD who only had two radiological evaluations, but had demonstrated significant decreases in tumor markers and tumor shrinkage of less than 30%, noted October 8, 2021.
$910.7 million

SRRK – Scholar Rock Holding Corporation
Apitegromab (SRK-015)
Spinal muscular atrophy (SMA)

$26.05
-0.40  -2%
Phase 2 Phase 2 late-breaker data showed an increase in RULM in both non-ambulatory cohorts. A greater increases in HFMSE (non-ambulatory) and Revised Hammersmith Scale (ambulatory) scores were seen in patients who were not limited by scoliosis or joint contractures, noted September 23, 2021. Phase 3 trial initiation expected by the end of 2021.
$897.7 million

TAK – Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of)
TAK-620 (maribavir)
Cytomegalovirus (CMV)

$14.07
+0.06  +0%
PDUFA priority review PDUFA priority review announced May 21, 2021, est. PDUFA priority review date November 2021 in accordance to the standard 6 month review period. FDA advisory committee voted unanimously to recommend use of maribavir to treat refractory cytomegalovirus (CMV) with or without genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients, noted October 7, 2021.
$44.3 billion

TPTX – Turning Point Therapeutics Inc.
Repotrectinib (TPX-0005) - TRIDENT-1
Non-small-cell lung cancer (NSCLC) and solid tumors

$43.44
-0.80  -2%
Phase 1/2 Phase 2 updated data from the Phase 1/2 trial noted in the population treated with one prior TKI and prior platinum-based chemotherapy the cORR was 39%. In populations with two prior TKIs without prior chemotherapy cORR was 30%. In populations with one prior TKI without prior chemotherapy the cORR was 38%. Dose modifications due to TEAEs included 27% of patients who had dose reduction and 11% who had drug discontinuation, noted October 7, 2021. Phase 2 date noted a confirmed ORR of 48% in patients with NTRK+ TKI-pretreated advanced solid tumors, 62% in NTRK+ TKI-pretreated advanced solid tumor patients with solvent front mutations and 41% in patients with NTRK+ TKI-naive advanced solid tumors, noted October 8, 2021. Breakthrough Therapy Designation announced October 4, 2021.
$2.1 billion

ZYNE – Zynerba Pharmaceuticals Inc.
Zygel (ZYN002) - BRIGHT
Autism Spectrum Disorder (ASD)

$3.84
-0.29  -7%
Phase 2 Phase 2 data released May 27, 2020. Trial achieved statistically significant and improvements from in all subscales of the Aberrant Behavior Checklist. Intends to meet FDA 1H 2021. Phase 2 long term data displayed a statistically significant improvement in ABC-C Subscale scores through 38 weeks. Only 7 patients (19%) experienced an AE that was deemed to be treatment related. Of the 10 treatment-related AEs reported, 7 were application site-related (application site reaction, pruritus, and dryness) and 1 each of sleep disorder, increased appetite, and pollakiuria, noted October 8, 2021.
$158.4 million